Contemporary Clinical Trials Communications最新文献

{"title":"Clinical efficacy of Xiaotan Sanjie decoction in treating gastric cancer with peritoneal metastases: A study protocol for a randomized controlled trial","authors":"Quan-yao Li ,&nbsp;Xi Li ,&nbsp;Hui Liu ,&nbsp;Ying Lu ,&nbsp;Zhao-wei Guo ,&nbsp;Wen-chao Qiu ,&nbsp;Pin-kang Wei ,&nbsp;Jun Shi","doi":"10.1016/j.conctc.2026.101612","DOIUrl":"10.1016/j.conctc.2026.101612","url":null,"abstract":"<div><h3>Background</h3><div>Gastric cancer (GC) is a highly prevalent malignancy worldwide. Approximately 20%–43% of patients present with peritoneal metastasis (PM) at initial diagnosis, resulting in a 5-year survival rate of less than 20%. Peritoneal metastasis frequently induces severe complications including malignant ascites and intestinal obstruction, significantly compromising patients' quality of life. Traditional Chinese Medicine (TCM) has demonstrated unique advantages in GC treatment. Xiaotan Sanjie (XTSJ) decoction, an empirical prescription based on the \"phlegm syndrome\" theory, has been shown in previous studies to inhibit GC proliferation and metastasis, modulate immune function, and enhance therapeutic efficacy while reducing toxicity. However, no scientific evidence currently supports the clinical efficacy of XTSJ decoction specifically in treating GC with peritoneal metastasis (GCPM). Therefore, this study aims to evaluate the efficacy and safety of XTSJ decoction in managing GCPM.</div></div><div><h3>Methods/Design</h3><div>The study protocol has been approved by the ethics committee and registered with the International Traditional Medicine Clinical Trial Registry. This prospective randomized controlled clinical trial will enroll 150 GCPM patients who will be randomly assigned in a 1:1 ratio to either the TCM treatment group or the conventional treatment group. Each group will undergo two treatment cycles totaling 6 weeks. The primary outcome measure is the clinical objective response rate (ORR). Secondary outcome measures include progression-free survival (PFS), overall survival (OS), tumor markers, peripheral blood immune indices, high-sensitivity modified Glasgow Prognostic Score (HS-mGPS), Karnofsky Performance Status (KPS) score, and Eastern Cooperative Oncology Group (ECOG) performance status score.</div></div><div><h3>Discussion</h3><div>This study investigates the synergistic mechanisms of integrated traditional Chinese and Western medicine in treating advanced GC, aiming to provide scientific evidence for the clinical application and further optimization of treatment strategies for GCPM.</div></div><div><h3>Conclusion</h3><div>This study will evaluate the efficacy and safety of XTSJ decoction combined with trastuzumab and chemotherapy in patients with GCPM through a randomized controlled trial, providing evidence-based basis for the integrated treatment of traditional Chinese and Western medicine.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101612"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147311013","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"IGROOVE: Protocol for a randomized, controlled, single-blind trial of dance intervention in older adults with subjective cognitive decline","authors":"Ayse Uneri ,&nbsp;Jason T. Fanning ,&nbsp;John R. Beck ,&nbsp;Edward H. Ip ,&nbsp;Paul J. Laurienti ,&nbsp;Jessie Laurita-Spanglet ,&nbsp;Robert G. Lyday ,&nbsp;Barbara J. Nicklas ,&nbsp;Bonnie C. Sachs ,&nbsp;Christina T. Soriano ,&nbsp;Christina E. Hugenschmidt","doi":"10.1016/j.conctc.2026.101617","DOIUrl":"10.1016/j.conctc.2026.101617","url":null,"abstract":"<div><h3>Background</h3><div>Accumulating evidence supports the importance of physical activity for maintaining or improving cognitive and cardiovascular health. Dance movement has been emerging as a form of physical activity that may protect and enhance physical and cognitive function in older adults. Research suggests that dance benefits cognitive health, cardiorespiratory fitness, mobility, and psychosocial function in older adults. However, the amount of dance movement needed to see these benefits cannot be ascertained from the highly heterogenous dance literature. This study aims to characterize the weekly frequency of dance movement needed to benefit cognitive and cardiorespiratory health over 6 months.</div></div><div><h3>Methods</h3><div>IGROOVE is a single-center, randomized, single-blind clinical trial that randomly assigns adults with subjective cognitive decline aged 62 years or older to one of 4 study conditions. Three of the conditions are 60-min dance classes attended once, twice, or three times a week, and the fourth condition is a control music appreciation class that meets once a week for 60 min, for 24 weeks. The primary aim of the study is to determine the optimal frequency of dance movement to achieve improvement in cognition and cardiorespiratory fitness.</div></div><div><h3>Discussion</h3><div>IGROOVE aims to fill a gap in the knowledge about the minimum number of weekly dance classes needed to see benefits in cognition and cardiorespiratory fitness by systematically exploring how the frequency of dance movement can affect cognitive function and cardiorespiratory fitness. This information will inform future definitive studies of dance and public health recommendations for dance as physical activity to promote healthy aging.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101617"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147327453","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Adjusting for intercurrent events using Bayesian joint models for longitudinal outcomes in clinical trials","authors":"Wen Teng ,&nbsp;Yongdong Ouyang ,&nbsp;Jose Dianti ,&nbsp;Niall D. Ferguson ,&nbsp;Ewan C. Goligher ,&nbsp;Anna Heath","doi":"10.1016/j.conctc.2026.101618","DOIUrl":"10.1016/j.conctc.2026.101618","url":null,"abstract":"<div><h3>Background:</h3><div>Intercurrent events in clinical trials can disrupt the interpretation and/or measurement of clinical endpoints. This article focuses on terminal intercurrent events that preclude complete measurement of a longitudinal outcome. When such events are related to the underlying outcome, particularly for physical signs, analyses based only on the available measurements can yield biased estimates. Consequently, a principled methodology is needed to effectively handle these intercurrent events.</div></div><div><h3>Methods:</h3><div>We propose a Bayesian joint modeling approach to account for terminal intercurrent events. Our model jointly analyzes longitudinal outcomes and terminal events using shared random effects. We employ multiple discrete-time survival submodels to accommodate different event types and evaluate operating characteristics through extensive simulations that resemble a clinical trial with recovery and death as competing events.</div></div><div><h3>Results:</h3><div>The proposed Bayesian joint modeling strategy demonstrates higher power than models that do not account for intercurrent events. Specifically, power increases by approximately 15% when bias due to intercurrent events is substantial and can be reduced by joint modeling.</div></div><div><h3>Conclusion:</h3><div>Our Bayesian joint modeling approach effectively addresses terminal intercurrent events in both the design and analysis phases of clinical trials. By explicitly accounting for event-related truncation of longitudinal follow-up, it improves the precision and reliability of treatment effect estimation when outcome measurement is incomplete.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101618"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147277315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The efficacy of home-based virtual reality exposure therapy as an add-on to behavioral therapy for children with selective mutism: Protocol for a single-case experimental design","authors":"Wendy van Vlerken ,&nbsp;Jeroen S. Legerstee ,&nbsp;Robert G. Belleman ,&nbsp;Samantha Bouwmeester ,&nbsp;Lynn F. Meester ,&nbsp;Annelot Roorda ,&nbsp;Ramón J.L. Lindauer ,&nbsp;Elisabeth M.W.J. Utens ,&nbsp;Luuk Stapersma","doi":"10.1016/j.conctc.2026.101602","DOIUrl":"10.1016/j.conctc.2026.101602","url":null,"abstract":"<div><h3>Background</h3><div>Selective Mutism (SM) is a rare childhood anxiety disorder characterized by an inability to speak in specific social situations, despite speaking freely in others. School is typically the environment where the disorder manifests itself most clearly. Children with SM often have difficulty generalizing speaking across different social situations. Parents and teachers often struggle to practice speaking with the child outside of therapy due to practical reasons and time constraints. Virtual Reality Exposure Therapy (VRET) at home has potential to enhance the treatment of SM by providing an alternative and engaging method for delivering exercises that support behavioral treatment.</div></div><div><h3>Methods</h3><div>This paper describes the development of the VRET application Speaking at School-VR and the methodology of the single case experimental design (SCED) to evaluate the feasibility and preliminary effects of the behavioral treatment at school, complemented with VRET at home, for children with SM, aged 4–13. A secondary aim is to evaluate the feasibility and adherence of home-based VRET based on qualitative information to capture participants’ experiences. A total of 15 children with SM and their families will be enrolled in the study to examine the potential effectiveness of the combined treatment. The treatment consists of 10 behavioral steps, each accompanied by complementary VRET exercises.</div></div><div><h3>Conclusion</h3><div>This is the first study to examine the feasibility and the potential effectiveness of home-delivered VRET as an adjunct to behavioral treatment for children with SM. The addition of VRET to behavioral treatment has the potential to enhance the generalization and transfer of skills across different situations in a facilitative and engaging way.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101602"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147277329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effects of high-protein vs conventional protein enteral nutrition on intestinal permeability, severity of disease, and mortality in critically ill intensive care unit Patients: Protocol for a randomized controlled trial","authors":"Shonaz Ahmadikhatir ,&nbsp;Pardis Irandoost ,&nbsp;Omid Moradi Moghaddam ,&nbsp;Mohammad Safarian","doi":"10.1016/j.conctc.2026.101621","DOIUrl":"10.1016/j.conctc.2026.101621","url":null,"abstract":"<div><h3>Background</h3><div>Intestinal permeability is an important determinant in intensive care unit patients. Enteral nutrition is vital for nutritional supplementation in critically ill ICU patients. The amount of Enteral nutrition protein and its impact on intestinal barrier permeability and function are challenging issues. Zonulin is a protein that regulates intestinal epithelial cell tight junction permeability and has the potential to be used as a biomarker for assessing the integrity of the intestinal barrier. However, there are few data from studies on intestinal permeability and the effects of enteral feeding of protein on zonulin levels in critically ill patients. This study was conducted to investigate the effect of high-protein enteral nutrition on intestinal permeability in ICU patients.</div></div><div><h3>Methods</h3><div>Participants were selected from 88 adult patients with critical illness aged 18-65 years who were admitted to the ICU of Hazrat Rasoul Akram Hospital in Tehran. In this randomized controlled clinical trial, patients will be allocated randomly into two groups of 44. The intervention group will receive high-protein (HP) enteral nutrition (1.6 g/kg/day), and the control group will receive conventional-protein (CP) enteral nutrition (1.2 g/kg/day) for 10 days. The primary outcome will be the change in serum Zonulin levels during the intervention period. Zonulin will be measured on days 0, 5, and 10. The SOFA, APACHE II, and mNUTRIC scores will also be assessed. Mortality will be calculated at 30 and 60 days after the intervention. The secondary outcomes will be SOFA score and 30- and 60-day mortality.</div></div><div><h3>Discussion</h3><div>Our study aims to present new evidence about the role of protein in enteral nutrition on intestinal permeability in critically ill patients in the ICU.</div></div><div><h3>Trial registrations</h3><div>The clinical trial was registered on December 11, 2024 in the Iranian Registry of Clinical Trials (IRCT) (IRCT20241129063891N1).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101621"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147378962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Designing communication strategies to increase rural participation in clinical trials using the Health Belief Model and strategic communication","authors":"Dannell Boatman ,&nbsp;Stephenie Kennedy-Rea ,&nbsp;Jay Mason ,&nbsp;Jessica Thayer ,&nbsp;Rebecca Reece ,&nbsp;Joanna Bailey ,&nbsp;Sarah Hansen ,&nbsp;Chelsea Norton ,&nbsp;Markie McCoy ,&nbsp;Sally Hodder","doi":"10.1016/j.conctc.2026.101610","DOIUrl":"10.1016/j.conctc.2026.101610","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101610"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146154176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of a trauma center-based, technology enhanced stepped care intervention to promote the mental health recovery of adolescent traumatic injury survivors","authors":"Tatiana M. Davidson ,&nbsp;Theresa Skojec ,&nbsp;Priscilla Li ,&nbsp;Leigh E. Ridings ,&nbsp;Hannah Espeleta ,&nbsp;Sarah German ,&nbsp;Martina Mueller ,&nbsp;Robert Gates ,&nbsp;David Mooney ,&nbsp;Robert Russell ,&nbsp;Terri deRoon-Cassini ,&nbsp;Kenneth Ruggiero","doi":"10.1016/j.conctc.2026.101622","DOIUrl":"10.1016/j.conctc.2026.101622","url":null,"abstract":"<div><h3>Background</h3><div>Pediatric traumatic injury (PTI) is a leading cause of hospitalization and long-term morbidity among U.S. youth, with approximately 30% developing posttraumatic stress or depression. Despite clear mandates from the American College of Surgeons (ACS) for behavioral health screening and referral, few pediatric trauma centers have the infrastructure to deliver coordinated mental health care. The Trauma Resilience and Recovery Program (TRRP) is a stepped-care, technology-enhanced model designed to promote psychological recovery following injury. This study evaluates the effectiveness of TRRP and identifies factors influencing its integration within pediatric trauma settings.</div></div><div><h3>Chods</h3><div>This multi-site, Type I hybrid effectiveness–implementation trial will recruit 300 adolescents (ages 12–17) hospitalized for traumatic injury and their caregivers across three pediatric trauma centers. Participants are randomized to TRRP or Enhanced Usual Care (EUC). TRRP includes bedside psychoeducation, risk screening, a brief coping skills intervention, automated text-based symptom monitoring, 30-day follow-up screening, and referral to evidence-based mental health care as needed. Primary outcomes (PTSD, depression, quality of life) are assessed at baseline, 3, 6, and 12 months. Qualitative interviews with families and trauma personnel, guided by the Consolidated Framework for Implementation Research (CFIR), will explore barriers and facilitators to implementation. Quantitative data will be analyzed using mixed-effects models; qualitative data will undergo thematic analysis.</div></div><div><h3>Conclusions</h3><div>This study will provide critical evidence on the clinical effectiveness and real-world integration of TRRP for adolescent trauma survivors. Findings will inform a scalable roadmap for embedding evidence-based behavioral health care into pediatric trauma systems to improve recovery and long-term well-being.</div><div>Clinicaltrials.gov idNCT05086757.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101622"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147356915","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of transoral robotic surgery of the base of the tongue vs. conservative treatment for obstructive sleep apnea, a RCT, the RAPID study protocol","authors":"A.G.L. Toppenberg ,&nbsp;J. van der Maten ,&nbsp;M. Bos ,&nbsp;W.J. Schuiling ,&nbsp;W.L. Lodder ,&nbsp;L.Q. Schwandt","doi":"10.1016/j.conctc.2026.101619","DOIUrl":"10.1016/j.conctc.2026.101619","url":null,"abstract":"<div><h3>Background</h3><div>CPAP is the gold standard treatment for obstructive sleep apnea (OSA) but suffers from poor long-term compliance. Alternatives like mandibular advancement devices (MADs) and surgery, such as transoral robotic surgery (TORS), are available, but their comparative efficacy is unclear.</div></div><div><h3>Study objective</h3><div>This study aims to evaluate whether base of the tongue (BOT) reduction using TORS is equal or superior to CPAP and MADs in improving quality of sleep and life in patients with moderate to severe OSA eligible for surgery.</div></div><div><h3>Study design</h3><div>A prospective randomized controlled trial.</div></div><div><h3>Population</h3><div>Patients eligible for TORS and CPAP or MAD aged &gt;18 years with moderate to severe OSA (Apnea Hypopnea Index &gt;15) untreated before.</div></div><div><h3>Interventions</h3><div>In total 50 patients, 25 in each treatment arm will be randomized to either TORS or non-surgical therapy (CPAP or MAD depending on preference of patient or physician).</div></div><div><h3>Outcome measures</h3><div>Primary outcomes will include improvement in sleep apnea severity measured through the apnea hypopnea index (AHI) and oxygen desaturation index (ODI)4%. Secondary outcomes will assess long-term quality of life compared to non-surgical therapy and adherence to devices.</div></div><div><h3>Results</h3><div>The data will be analysed on an Intention-To-Treat principle (ITT). Ethical approval was obtained from RTPO in September of 2023. Trial registration number: NL84446.099.23 METCnumber UMCG25.327. Outcomes will be published in peer reviewed journals and presented at (inter)national conferences.</div></div><div><h3>Discussion</h3><div>Findings of this study will address the evidence gap in the comparative effectiveness of TORS versus non-surgical therapies for OSA and may inform future clinical decision making and guideline development.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101619"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147378888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rural targeted messaging, multiplex salivary measurement, and rural equity in SARS-CoV-2 antibody testing: Protocol overview of a SeroNet investigation","authors":"Leah Maschino ,&nbsp;Kelly A. Hirko ,&nbsp;Christopher D. Heaney ,&nbsp;Douglas A. Granger ,&nbsp;Steve W. Granger ,&nbsp;Anurag Dawadi ,&nbsp;Lindsey Rose ,&nbsp;Monicia Summers ,&nbsp;Nora Pisanic ,&nbsp;Olivia Aspiras ,&nbsp;Stefan M.M. Goetz ,&nbsp;Todd Lucas","doi":"10.1016/j.conctc.2026.101627","DOIUrl":"10.1016/j.conctc.2026.101627","url":null,"abstract":"<div><h3>Background</h3><div>Rural communities were disproportionately impacted by the COVID-19 pandemic. Current and future pandemic preparedness in rural areas could be aided by serological (antibody) testing. However, benefits to be gained from serosurveillance are challenged both by the accessibility of serological testing resources in hard-to-reach rural areas, and by likely hesitancy towards their use in many rural communities. Trials are needed to evaluate outreach and health communication strategies that can increase rural receptivity towards serosurveillance.</div></div><div><h3>Methods</h3><div>We conducted a two-arm randomized controlled trial that recruited N = 194 participants from rural northern Michigan. In a single online session lasting approximately 45 min, participants were randomly assigned to view either a general SARS-CoV-2 antibody testing didactic video, or a rural targeted didactic video co-created with a rural community advisory board and containing unique rural messaging. Primary self-report outcomes included receptivity to antibody testing, as well as activation of medical mistrust and concern for rural-discrimination in future SARS-CoV-2 antibody testing. We also developed and provided an opportunity to participate in a home-based salivary antibody screening program. In addition to assessing the feasibility and fidelity of this program, we assessed interest and full participation in the serosurveillance program as behavioral outcomes.</div></div><div><h3>Discussion</h3><div>Findings from this study can guide the use of home-based screening programs and targeted health communication strategies to promote greater uptake of health resources in rural communities. In doing so, study results can also guide public health strategies to reduce pandemic-related and other rural health disparities.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101627"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147386262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The HEART-GP strategy for ruling out acute coronary syndrome in out-of-hours primary care: a diagnostic accuracy trial protocol","authors":"Indra M.B. Melessen ,&nbsp;Jelle C.L. Himmelreich ,&nbsp;Amy Manten ,&nbsp;Edanur Sert ,&nbsp;Simone van den Bulk ,&nbsp;Tobias N. Bonten ,&nbsp;Martijn H. Rutten ,&nbsp;Eric P. Moll van Charante ,&nbsp;Ralf E. Harskamp","doi":"10.1016/j.conctc.2026.101624","DOIUrl":"10.1016/j.conctc.2026.101624","url":null,"abstract":"<div><h3>Background</h3><div>Acute coronary syndrome (ACS) is a life-threatening condition that requires rapid identification to prevent morbidity and mortality. Differentiating ACS from benign conditions remains difficult in out-of-hours primary care (OOH-PC) settings due to non-specific and overlapping symptom profiles, and limited diagnostic resources. Current guidelines promote a low threshold for emergency department (ED) referral. Despite this cautious approach, ACS cases are still missed. The arrival of high-sensitivity troponin (hs-troponin) point-of-care testing (POCT) may enable safer, faster, and more efficient diagnosis.</div></div><div><h3>Methods and analysis</h3><div>This multicenter prospective diagnostic accuracy trial evaluates the <em>HEART-GP strategy</em>, combining a single fingerstick hs-troponin test with clinical assessment and optional ECG. Adults (≥18 years) presenting with acute chest pain or discomfort to one of four participating Dutch OOH-PC centers are eligible. The primary outcome is the occurrence of major adverse cardiovascular events a composite of death, ACS, or urgent revascularization within six weeks. Diagnostic safety (sensitivity, negative predictive value) and efficiency (ED referral reduction) will be compared against standard care. Secondary analyses will assess the value of sex-specific cut-offs and integration with existing risk scores.</div></div><div><h3>Anticipated results</h3><div>We anticipate that the <em>HEART-GP strategy</em> will demonstrate improved diagnostic safety along with efficiency gains in OOH-PC. Our straightforward rapid rule-out strategy holds promise to be widely implemented in primary care settings to advance the evaluation of acute chest pain.</div></div><div><h3>Ethics</h3><div>The study was approved by the Medical Research Ethics Committee of the Amsterdam UMC (NL82428.000.22, 02-03-2023) and registered in the ISRCTN-registry (ISRCTN11954040 <span><span>https://doi.org/10.1186/ISRCTN11954040</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"50 ","pages":"Article 101624"},"PeriodicalIF":1.4,"publicationDate":"2026-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147356931","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}