{"title":"Should all patients receive dual chamber pacing ICDs? The rationale for the DAVID trial","authors":"B. Wilkoff","doi":"10.1186/cvm-2-5-215","DOIUrl":"https://doi.org/10.1186/cvm-2-5-215","url":null,"abstract":"","PeriodicalId":53230,"journal":{"name":"Current Controlled Trials in Cardiovascular Medicine","volume":"27 1","pages":"215 - 217"},"PeriodicalIF":0.0,"publicationDate":"2001-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85436715","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":"Do we need clinical trials to test the ability of transdermal HRT to prevent coronary heart disease?","authors":"D. Crook","doi":"10.1186/cvm-2-5-211","DOIUrl":"https://doi.org/10.1186/cvm-2-5-211","url":null,"abstract":"","PeriodicalId":53230,"journal":{"name":"Current Controlled Trials in Cardiovascular Medicine","volume":"2 1","pages":"211 - 214"},"PeriodicalIF":0.0,"publicationDate":"2001-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89498683","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":"Design and intermediate results of the Lower Extremity Arterial Disease Event Reduction (LEADER)* trial of bezafibrate in men with lower extremity arterial disease [ISRCTN41194621]","authors":"T. Meade","doi":"10.1186/cvm-2-4-195","DOIUrl":"https://doi.org/10.1186/cvm-2-4-195","url":null,"abstract":"","PeriodicalId":53230,"journal":{"name":"Current Controlled Trials in Cardiovascular Medicine","volume":"30 1","pages":"195 - 204"},"PeriodicalIF":0.0,"publicationDate":"2001-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80946233","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}
Kenneth W Mahaffey, Robert A Harrington, Martijn Akkerhuis, Neal S Kleiman, Lisa G Berdan, Brian S Crenshaw, Barbara E Tardiff, Christopher B Granger, Ingrid DeJong, Manju Bhapkar, Petr Widimsky, Ramón Corbalon, Kerry L Lee, Jaap W Deckers, Maarten L Simoons, Eric J Topol, Robert M Califf
{"title":"Systematic adjudication of myocardial infarction end-points in an international clinical trial.","authors":"Kenneth W Mahaffey, Robert A Harrington, Martijn Akkerhuis, Neal S Kleiman, Lisa G Berdan, Brian S Crenshaw, Barbara E Tardiff, Christopher B Granger, Ingrid DeJong, Manju Bhapkar, Petr Widimsky, Ramón Corbalon, Kerry L Lee, Jaap W Deckers, Maarten L Simoons, Eric J Topol, Robert M Califf","doi":"10.1186/cvm-2-4-180","DOIUrl":"https://doi.org/10.1186/cvm-2-4-180","url":null,"abstract":"<p><p>BACKGROUND: Clinical events committees (CEC) are used routinely to adjudicate suspected end-points in cardiovascular trials, but little information has been published about the various processes used. We reviewed results of the CEC process used to identify and adjudicate suspected end-point (post-enrolment) myocardial infarction (MI) in the large Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin (Eptifibatide) Therapy (PURSUIT) trial. METHODS: The PURSUIT trial randomised 10,948 patients with acute coronary syndromes to receive eptifibatide or placebo. A central adjudication process was established prospectively to identify all suspected MIs and adjudicate events based on protocol definitions of MI. Suspected MIs were identified by systematic review of data collection forms, cardiac enzyme results, and electrocardiograms. Two physicians independently reviewed all suspected events. If they disagreed whether a MI had occurred, a committee of cardiologists adjudicated the case. RESULTS: The CEC identified 5005 patients with suspected infarction (46%), of which 1415 (28%) were adjudicated as end-point infarctions. As expected, the process identified more end-point events than did the site investigators. Absolute and relative treatment effects of eptifibatide were smaller when using CEC-determined MI rates rather than site investigator-determined rates. The site-investigator reporting of MI and the CEC assessment of MI disagreed in 20% of the cases reviewed by the CEC. CONCLUSIONS: End-point adjudication by a CEC is important, to provide standardised, systematic, independent, and unbiased assessment of end-points, particularly in trials that span geographic regions and clinical practice settings. Understanding the CEC process used is important in the interpretation of trial results and event rates.</p>","PeriodicalId":53230,"journal":{"name":"Current Controlled Trials in Cardiovascular Medicine","volume":"2 4","pages":"180-186"},"PeriodicalIF":0.0,"publicationDate":"2001-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1186/cvm-2-4-180","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71429121","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
K. Mahaffey, R. Harrington, M. Akkerhuis, N. Kleiman, L. Berdan, B. Crenshaw, B. Tardiff, C. Granger, Ingrid DeJong, M. Bhapkar, P. Widimsky, Ramón Corbalón, Kerry L Lee, J. Deckers, M. Simoons, E. Topol, R. Califf
{"title":"Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study","authors":"K. Mahaffey, R. Harrington, M. Akkerhuis, N. Kleiman, L. Berdan, B. Crenshaw, B. Tardiff, C. Granger, Ingrid DeJong, M. Bhapkar, P. Widimsky, Ramón Corbalón, Kerry L Lee, J. Deckers, M. Simoons, E. Topol, R. Califf","doi":"10.1186/cvm-2-4-187","DOIUrl":"https://doi.org/10.1186/cvm-2-4-187","url":null,"abstract":"","PeriodicalId":53230,"journal":{"name":"Current Controlled Trials in Cardiovascular Medicine","volume":"14 1","pages":"187 - 194"},"PeriodicalIF":0.0,"publicationDate":"2001-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75742888","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":"How long should angiotensin-converting enzyme inhibitors be given to patients following myocardial infarction: implications of the HOPE trial","authors":"V. Bonarjee, K. Dickstein","doi":"10.1186/cvm-2-4-151","DOIUrl":"https://doi.org/10.1186/cvm-2-4-151","url":null,"abstract":"","PeriodicalId":53230,"journal":{"name":"Current Controlled Trials in Cardiovascular Medicine","volume":"62 1","pages":"151 - 155"},"PeriodicalIF":0.0,"publicationDate":"2001-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72770082","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 Myocardial Ischemia Reduction with Acute Cholesterol Lowering (MIRACL) trial: a new frontier for statins?","authors":"D. Waters, G. Schwartz, A. Olsson","doi":"10.1186/cvm-2-3-111","DOIUrl":"https://doi.org/10.1186/cvm-2-3-111","url":null,"abstract":"","PeriodicalId":53230,"journal":{"name":"Current Controlled Trials in Cardiovascular Medicine","volume":"10 1","pages":"111 - 114"},"PeriodicalIF":0.0,"publicationDate":"2001-05-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77773603","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}