Abstract:
:The early termination of clinical trials, for either benefit or harm, often generates undue enthusiasm or alarm. The enhanced publicity attending early termination of a trial promotes inappropriate interpretations because of the inherent difficulty of a prompt and comprehensive data review. Furthermore, the process of monitoring the accumulating outcome data for early evidence of treatment benefit or harm is fraught with many statistical and methodological difficulties. This report from a Task Force convened by the Working Group on Arrhythmias of the European Society of Cardiology incorporates first, a series of trials terminated appropriately or inappropriately for benefit or harm and used as examples to illustrate the importance of suitable trial design and of proper stopping rules; second, a description of the committee structure of a clinical trial; third, an analysis of the general design issues; fourth, a review of the main issues in interim analysis with special reference to main strategies for reducing the rate of false-positive claims that could result from early trial termination; and finally, a series of specific recommendations concerning the design, structure, analysis, interpretation, and presentation of a clinical trial.
journal_name
Eur Heart Jjournal_title
European heart journalauthors
subject
Has Abstractpub_date
1994-06-01 00:00:00pages
721-38issue
6eissn
0195-668Xissn
1522-9645journal_volume
15pub_type
杂志文章abstract:: ...
journal_title:European heart journal
pub_type: 评论,杂志文章
doi:10.1093/eurheartj/ehz081
更新日期:2019-03-14 00:00:00
abstract:AIMS:To assess the diagnostic accuracy of 256-row computed tomographic angiography (CTA) in patients with suspected coronary artery disease (CAD). Non-invasive imaging of the coronary artery by CTA has increasingly been used in recent years. The accuracy of 256-row CTA has not yet been studied. We sought to assess the ...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehq072
更新日期:2010-08-01 00:00:00
abstract:AIMS:Our aims were to evaluate the distribution of troponin I concentrations in population cohorts across Europe, to characterize the association with cardiovascular outcomes, to determine the predictive value beyond the variables used in the ESC SCORE, to test a potentially clinically relevant cut-off value, and to ev...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehw172
更新日期:2016-08-07 00:00:00
abstract::Infective endocarditis is associated with significant morbidity and mortality, with valvular destruction and congestive heart failure being more common in patients with echocardiographically discernible vegetations. The transoesophageal approach affords consistently high quality images with excellent structural resolu...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a060195
更新日期:1992-04-01 00:00:00
abstract:AIMS:Carotid-femoral pulse wave velocity (PWV), a direct measure of aortic stiffness, has become increasingly important for total cardiovascular (CV) risk estimation. Its application as a routine tool for clinical patient evaluation has been hampered by the absence of reference values. The aim of the present study is t...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究
doi:10.1093/eurheartj/ehq165
更新日期:2010-10-01 00:00:00
abstract:AIMS:The relative benefits of computed tomography coronary angiography (CTCA)-guided management in women and men with suspected angina due to coronary heart disease (CHD) are uncertain. METHODS AND RESULTS:In this post hoc analysis of an open-label parallel-group multicentre trial, we recruited 4146 patients referred ...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehz903
更新日期:2020-04-01 00:00:00
abstract:AIMS:Patients with diabetes are at excessive risk of mortality and cardiovascular morbidity. Previous studies suggest that aspirin may be less effective in diabetic patients. In this multi-centre, randomized, double blind trial picotamide, a dual inhibitor of thromboxane A2 synthase and receptor, was compared with aspi...
journal_title:European heart journal
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/j.ehj.2004.07.013
更新日期:2004-10-01 00:00:00
abstract::Twenty-one consecutive patients with testicular cancer treated with bleomycin, vinblastine, and cisplatin (PVB) were evaluated for acute vascular ischaemic events during chemotherapy. Angina pectoris occurred in 8/21 (38%) patients, a median 5.6 weeks after initiation of chemotherapy and persisted for 2-7 days. Raynau...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a062542
更新日期:1988-05-01 00:00:00
abstract:AIMS:The purpose of the Euro Heart Survey Programme of the European Society of Cardiology is to evaluate to which extent clinical practice endorses existing guidelines as well as to identify differences in population profiles, patient management, and outcome across Europe. The current survey focuses on the invasive dia...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究
doi:10.1093/eurheartj/ehi238
更新日期:2005-06-01 00:00:00
abstract::Alterations in the right ventricular function may or may not contribute to progressive cardiac dysfunction after left ventricular infarction. Ligation of the left coronary artery (LCAL) was lethal within 24 h for 25% of 100 rats, whereas none of 21 sham-operated rats died. No rats died during the following 4 weeks, af...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/14.11.1554
更新日期:1993-11-01 00:00:00
abstract:AIMS:Non-vitamin K antagonist oral anticoagulants (NOACs) require dose reductions according to patient or clinical factors for patients with atrial fibrillation (AF). In this meta-analysis, we aimed to assess outcomes with reduced-dose NOACs when given as pre-specified in pivotal trials. METHODS AND RESULTS:Aggregated...
journal_title:European heart journal
pub_type: 杂志文章,meta分析
doi:10.1093/eurheartj/ehy802
更新日期:2019-05-14 00:00:00
abstract::The advent of platelet membrane glycoprotein (GP) IIb/IIIa inhibitors has changed the landscape of interventional cardiology. Given the commercial availability of abciximab and expected regulatory approvals for other receptor blockers, defining appropriate use of these agents in the interventional setting is mandated....
journal_title:European heart journal
pub_type: 杂志文章,评审
doi:
更新日期:1998-04-01 00:00:00
abstract::Antiarrhythmic agents may depress cardiac contractility and worsen heart failure. Flecainide is an effective antiarrhythmic drug, but when administered orally in patients with left ventricular (LV) dysfunction, its effect on LV function is unknown. To assess the effects of flecainide on cardiac function, LV ejection f...
journal_title:European heart journal
pub_type: 临床试验,杂志文章
doi:10.1093/eurheartj/8.7.754
更新日期:1987-07-01 00:00:00
abstract::Oxygen consumption was measured during 30 min of work in 16 patients, after a myocardial infarction (anterior or posterior), and compared with 16 normal subjects, of the same age, involved in the same activities, in a steel factory. The VO2 at work of the patients was a little lower than in normals. The mean heart rat...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/9.suppl_l.54
更新日期:1988-11-01 00:00:00
abstract:AIMS:The totally subcutaneous implantable-defibrillator (S-ICD) is a new alternative to the conventional transvenous ICD system to minimize intravascular lead complications. There are limited data describing the long-term performance of the S-ICD. This paper presents the first large international patient population col...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究
doi:10.1093/eurheartj/ehu112
更新日期:2014-07-01 00:00:00
abstract:AIMS:Drug-eluting stents (DES) represent a major advance in interventional cardiology. Along with the success shown, current DES also present limitations related to the presence of polymer-coating, fixed drug, and dose used. With the ISAR (Individualized Drug-Eluting Stent System to Abrogate Restenosis) project, a DES ...
journal_title:European heart journal
pub_type: 临床试验,杂志文章
doi:10.1093/eurheartj/ehi405
更新日期:2005-08-01 00:00:00
abstract::Cardiac troponins (cTns) I and T have long been the most successful cardiac-specific circulating biomarkers in cardiovascular (CV) medicine, having changed dramatically the diagnosis of acute myocardial infarction, while being independent predictors of outcome in several cardiac conditions and non-cardiac conditions. ...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehaa083
更新日期:2020-11-01 00:00:00
abstract:AIMS:Statins reduce cardiovascular risk in patients with acute coronary syndrome (ACS) and normal-to-moderately impaired renal function. It is not known whether proprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors provide similar benefit across a range of renal function. We determined whether effects of the...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehaa498
更新日期:2020-11-07 00:00:00
abstract:OBJECTIVE:To examine the atherogenic risk-reducing effect of bezafibrate and lovastatin. DESIGN, SETTING, PATIENTS, INTERVENTIONS:Double-blind, randomized clinical trial of male and female patients with moderate hypercholesterolaemia with or without hypertriglyceridaemia. Two months dietary treatment followed by 400 m...
journal_title:European heart journal
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1093/oxfordjournals.eurheartj.a060769
更新日期:1995-11-01 00:00:00
abstract:AIMS:Left ventricular outflow tract obstruction (LVOTO) is associated with reduced survival in patients with hypertrophic cardiomyopathy (HCM). The influence of LVOTO on survival from SD in relation to other recognized clinical risk markers is unknown. METHODS AND RESULTS:A total of 917 patients with HCM (554 males, 4...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehl041
更新日期:2006-08-01 00:00:00
abstract::Right ventricular dysplasia (RVD) is a cardiac anomaly characterized by replacement of right ventricular myocardium by adipose and fibrous tissue that was first described at autopsy, and is now being recognized pre-mortem. Sudden death and ventricular arrhythmias are the most common clinical manifestation of the condi...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/10.suppl_d.84
更新日期:1989-09-01 00:00:00
abstract::Chronically ischaemic myocardium from patients with coronary heart disease was investigated by light and electron microscopy using tissue biopsies taken during cardiac surgery. Light microscopy showed a significantly increased amount of fibrotic material, cell size was variable. By electron microscopy, the most obviou...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/9.suppl_a.141
更新日期:1988-01-01 00:00:00
abstract:AIM:The present study aimed to assess the benefits of two-stent techniques for patients with DEFINITION criteria-defined complex coronary bifurcation lesions. METHODS AND RESULTS:In total, 653 patients with complex bifurcation lesions at 49 international centres were randomly assigned to undergo the systematic two-ste...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehaa543
更新日期:2020-07-14 00:00:00
abstract:AIMS:We recently found that resting muscle sympathetic nerve activity is inversely related to peak oxygen uptake (VO(2) peak) in patients with heart failure, suggesting a peripheral neurogenic limit to exercise in heart failure. No such relationship was observed in healthy controls. To determine whether this observatio...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1053/euhj.2001.2942
更新日期:2002-05-01 00:00:00
abstract::We conducted a survey by questionnaire to assess whether patients 'at risk' from infective endocarditis are aware of the need for good dental hygiene and antibiotic prophylaxis, and receive appropriate advice or treatment. Of 189 patients surveyed, half had told a dentist about their heart, 8% were aware of a dental p...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/14.6.812
更新日期:1993-06-01 00:00:00
abstract:AIMS:We sought to assess the effect of clopidogrel on clinical events 1 year after discharge in survivors of ST-elevation myocardial infarction (STEMI) in clinical practice. METHODS AND RESULTS:We analysed data of consecutive survivors of acute STEMI and either concomitant therapy with aspirin or aspirin plus clopidog...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究
doi:10.1093/eurheartj/ehl317
更新日期:2006-11-01 00:00:00
abstract::The safety of calcium antagonists has recently become a controversial issue among cardiologists. Thus, the role of calcium antagonists in the treatment of myocardial infarction and in secondary cardiovascular prevention is under review. As a consequence, the concept that the words 'calcium antagonists' comprise variou...
journal_title:European heart journal
pub_type: 杂志文章,评审
doi:10.1093/eurheartj/18.suppl_a.56
更新日期:1997-01-01 00:00:00
abstract:AIMS:Resuscitated cardiac arrest (CA), leading to harmful cardiovascular dysfunction and multiple organ failure, includes a whole-body hypoxia-reoxygenation phenomenon. Opening of the mitochondrial permeability transition pore (mPTP) appears to be a pivotal event in ischaemia-reperfusion injury. We hypothesized that ph...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehq112
更新日期:2011-01-01 00:00:00
abstract:Aims:Epidemiological studies strongly suggest a link between stress, depression, and cardiovascular diseases (CVDs); the mechanistic correlation, however, is poorly understood. A single-nucleotide polymorphism in the BDNF gene (BDNFVal66Met), associated with depression and anxiety, has been proposed as a genetic risk f...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehv655
更新日期:2017-05-07 00:00:00
abstract::A 45-year-old patient with the Wolff-Parkinson-White syndrome suffering from recurrent intractable reciprocating atrioventricular tachycardia (RAVT) is reported. He used amiodarone, sotalol, quinidine, propafenone and flecainide unsuccessfully. An electrophysiological study (EPS) performed with four catheters localize...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/12.12.1321
更新日期:1991-12-01 00:00:00