Abstract:
:Randomized clinical trials (RCTs) are the definitive contributors to evidence-based medicine. RCTs assessing serious outcomes in cardiovascular disease have grown, with 'megatrials' becoming more common with the realization that wrong conclusions resulted from random error in inadequately sized trials. Simple design and a heterogeneous patient population were early features, but multinational trials have increased in scientific, logistical, bureaucratic, regulatory, and legal complexity. These studies now exceed the financial means of academia or medical charities. Governments have left the bill with the pharmaceutical industry, encouraging a symbiosis with academics, who contribute medical and scientific expertise, and access to patients. Industry provides pharmacological, pharmaceutical, technical and regulatory know-how, good clinical practice expertise, and legal assistance during the trial. Study supervision is then in the hands of an independent steering committee and associated subcommittees, until appropriate dissemination of results. Prospectively defined interaction with the sponsor facilitates unbiased design and conduct, but arrangements need careful implementation to avoid conflicts of interest. The patient is protected by a strong data safety monitoring board that is wholly independent. Megatrials are under threat from over-regulation, increasing costs, and difficulties in execution. These issues merit urgent public and political education and debate.
journal_name
Eur Heart Jjournal_title
European heart journalauthors
Hilbrich L,Sleight Pdoi
10.1093/eurheartj/ehl152subject
Has Abstractpub_date
2006-09-01 00:00:00pages
2158-64issue
18eissn
0195-668Xissn
1522-9645pii
ehl152journal_volume
27pub_type
杂志文章,评审abstract::Transthoracic echocardiography and continuous wave Doppler were prospectively performed in 132 out-patients with suspicion of pulmonary embolism, and who had no previous history of severe cardiac or pulmonary disease. Bedside echocardiography determined diagnosis other than pulmonary embolism in 55 patients. Further s...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a014946
更新日期:1996-05-01 00:00:00
abstract::In this double-blind placebo-controlled study with enalapril, 74 patients with acute myocardial infarction were followed at 0, 7, 30, 60 and 180 days after the event. Platelets and leukocytes were activated during the first 7 days. During the 6-month period fibrinogen, leukocytes, elastase, and B beta 30-43 remained e...
journal_title:European heart journal
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1093/oxfordjournals.eurheartj.a060831
更新日期:1995-12-01 00:00:00
abstract:Aims:The differential impact on ischaemic and bleeding events of the type of drug-eluting stent [durable polymer stents [DES] vs. biodegradable polymer stents vs. bioresorbable scaffolds (BRS)] and length of dual antiplatelet therapy (DAPT) remains to be defined. Methods and results:Randomized controlled trials compar...
journal_title:European heart journal
pub_type: 杂志文章,meta分析,评审
doi:10.1093/eurheartj/ehx437
更新日期:2017-11-07 00:00:00
abstract::Forty patients with prosthetic valve endocarditis (PVE) presenting during a 12-year period at a single hospital were studied. Twenty-six were male and 14 female and ages ranged from 19 to 67 years. During the first six post-operative months, most episodes were caused by staphylococci (38%) and Gram negative bacilli (2...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/5.suppl_c.133
更新日期:1984-10-01 00:00:00
abstract::A 35-year-old man developed giant cell myocarditis resulting in severe congestive cardiac failure. He needed urgent orthotopic cardiac transplantation despite maximal doses of inotropes and augmentation with an intra-aortic balloon pump. The patient presented with rhythm disturbances and echocardiographically diminish...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a059938
更新日期:1991-04-01 00:00:00
abstract::A series of 42 patients with chest pain but normal coronary angiograms and normal haemodynamics at rest were prospectively classified as typical angina (group 1, N = 9) or atypical angina (group 2, N = 16) or non-anginal chest pain (group 3, N = 17). All patients underwent radionuclide ventriculography and measurement...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a062119
更新日期:1986-08-01 00:00:00
abstract:AIMS:Whether increased homocysteine is one mechanism linking obstructive sleep apnoea (OSA) to cardiovascular abnormalities is unclear. We hypothesised that plasma homocysteine would be higher in OSA patients than in control subjects, would increase further during sleep, and decrease after treatment with continuous pos...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1016/j.ehj.2004.05.018
更新日期:2004-08-01 00:00:00
abstract::Transesophageal echocardiographic evaluation of right and left pulmonary arteries, up to the origin of their lobar branches, was prospectively performed with a single plane probe in 32 consecutive patients (18 M, 14 F, aged 55.5 +/- 14.6, from 32 to 80 years) with clinical or echocardiographic suspicion of pulmonary e...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a060947
更新日期:1995-04-01 00:00:00
abstract:AIM:Few epidemiological data are available describing the sudden death of persons in their prime. This study aims to elucidate when and how sudden death occurs among employees. METHODS:A total of 196775 employees from 10 workplaces in Central Japan were surveyed for non-traumatic sudden death during 1989-1995. Demogra...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1053/euhj.1998.1189
更新日期:1999-03-01 00:00:00
abstract:AIMS:This study investigated whether sedentary behaviour and different activity levels have an independent association with carotid intima-media thickness (IMT) and with the 3-year IMT progression in different carotid segments. METHODS AND RESULTS:The study population included 614 healthy men and women (mean age = 44 ...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究
doi:10.1093/eurheartj/ehq092
更新日期:2010-06-01 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:The aim of this study was to assess whether perioperative N-acetylcysteine (NAC), an antioxidant, prevents acute renal injury (ARI) after cardiac surgery. METHODS AND RESULTS:We performed a systematic review of randomized controlled trials (RCTs) of NAC in adult cardiac surgery patients. The RCTs were identified ...
journal_title:European heart journal
pub_type: 杂志文章,meta分析,评审
doi:10.1093/eurheartj/ehp053
更新日期:2009-08-01 00:00:00
abstract::The present review discusses the prognostic significance of post-infarction angina pectoris, and the significance of post-infarction intervention with verapamil on the prevalence of post-infarction ischaemia and prognosis. Angina pectoris during the first month after acute myocardial infarction (AMI) was found to be a...
journal_title:European heart journal
pub_type: 杂志文章,评审
doi:10.1093/eurheartj/16.suppl_h.13
更新日期:1995-08-01 00:00:00
abstract:AIMS:Matrix metalloproteinase-1 (MMP-1), a proteolytic enzyme able to degrade types I and III collagens, is present in atherosclerotic lesions but absent from the normal blood vessel wall. The recent observation that, in a transgenic mouse model, MMP-1 gene expression slows the development and progression of atheroscle...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1016/s0195-668x(03)00385-3
更新日期:2003-09-01 00:00:00
abstract::Assessment of percutaneous transluminal coronary angioplasty (PTCA) by early radionuclide exercise test was evaluated for 11 arteries undergoing a successful procedure. Exercise thallium-201 (Tl-201) and radionuclide ventriculography (RNV) were performed within 3 days before and after PTCA and compared to % diameter s...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a062282
更新日期:1987-04-01 00:00:00
abstract:AIMS:To investigate personality traits and sympatho-vagal modulation of heart rate variability (HRV) during acute myocardial infarction (AMI), assessing their relationships and their long-term prognostic value. METHODS AND RESULTS:Psychological traits and 24 h HRV were prospectively investigated in 246 patients at dis...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究
doi:10.1093/eurheartj/ehi252
更新日期:2005-08-01 00:00:00
abstract:AIMS:Left ventricular (LV) ejection fraction (LVEF) is currently considered for the decision making of patients with mitral regurgitation (MR). However, LVEF represents change in LV volume between end-diastole and end-systole but does not characterize the intrinsic function of the myocardium. In contrast, speckle-track...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehv680
更新日期:2016-03-07 00:00:00
abstract:AIMS:This ancillary analysis of the GISSI-HF database aims at assessing the effect of rosuvastatin on the occurrence of atrial fibrillation (AF) in patients with chronic heart failure (HF) who were not in AF at study entry. METHODS AND RESULTS:GISSI-HF was a double-blind, placebo-controlled trial testing n-3 PUFA and ...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1093/eurheartj/ehp357
更新日期:2009-10-01 00:00:00
abstract:AIMS:To investigate the efficacy and safety of a cardiac resynchronization therapy with cardioverter-defibrillator (CRT-D) device with simplified ventricular tachycardia management in patients with non-ischaemic heart failure (HF) and primary prevention implantable cardioverter defibrillator (ICD) indication. METHODS ...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究
doi:10.1093/eurheartj/ehp247
更新日期:2009-11-01 00:00:00
abstract::The present review summarizes the available information on the effects of the three major classes of antianginal agents (nitrates, calcium and beta-blockers) on myocardial energy metabolism. It also discusses the role of some new molecules (L-carnitine, trimetazidine and ranolazine) that have been proposed as an alter...
journal_title:European heart journal
pub_type: 杂志文章,评审
doi:10.1093/eurheartj/14.suppl_g.2
更新日期:1993-11-01 00:00:00
abstract::A major challenge for all health care systems is to identify the most efficient use of limited and finite resources available for health care. Economic evaluation provides a balance sheet of the benefits, harms and costs for making choices between alternative health care services and is one strategy to assist decision...
journal_title:European heart journal
pub_type: 杂志文章,评审
doi:
更新日期:1998-11-01 00:00:00
abstract::A 22-year-old man who engaged in intense and regular physical exercise complained of atypical chest pain. The only remarkable abnormality found in the routine clinical work-up was a left posterior hemiblock. The echocardiogram and the magnetic resonance imaging (MRI) study showed a tumour in the posterior and superior...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a060217
更新日期:1992-04-01 00:00:00
abstract:BACKGROUND:The purpose of this study was to assess the independent contribution of left bundle branch block (LBBB) on long-term mortality in a large cohort with symptomatic heart failure (HF) requiring hospitalization. METHODS AND RESULTS:We studied a prospective cohort of 21 685 cases of symptomatic HF requiring hosp...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehm262
更新日期:2007-10-01 00:00:00
abstract:AIMS:Various definitions of major bleeding have been used to evaluate safety in randomized controlled trials of antiplatelet therapy. We compared the definitions and rates of major bleeding in phase III randomized controlled trials of oral P2Y(12) inhibitors in the management of patients with acute coronary syndromes (...
journal_title:European heart journal
pub_type: 杂志文章,meta分析,评审
doi:10.1093/eurheartj/ehr143
更新日期:2011-09-01 00:00:00
abstract::Three different bradycardic agents, alinidine, AQ-A39 and UL-FS49 increase the intrinsic cycle length of the isolated SA node preparation of the rabbit. This increase is mainly caused by a decrease in rate of diastolic depolarization. One of these agents, alinidine, was used to study the underlying ionic mechanism of ...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/8.suppl_l.25
更新日期:1987-12-01 00:00:00
abstract:AIMS:Recent randomized clinical trials have reported a reduction in restenosis with intracoronary stents and have suggested that this restenosis reduction is a result of the higher immediate luminal gain, in comparison to conventional percutaneous transluminal coronary angioplasty (PTCA). The hypothesis of this study i...
journal_title:European heart journal
pub_type: 临床试验,杂志文章
doi:10.1053/euhj.1997.0614
更新日期:1998-02-01 00:00:00
abstract:AIMS:Carotid intima-media thickness (CIMT) and plaque information can improve coronary heart disease (CHD) risk prediction when added to traditional risk factors (TRF). However, obtaining adequate images of all carotid artery segments (A-CIMT) may be difficult. Of A-CIMT, the common carotid artery intima-media thicknes...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究
doi:10.1093/eurheartj/ehr192
更新日期:2012-01-01 00:00:00
abstract::The epidemic of cardiovascular disease (CVD) is a global phenomenon, and the magnitude of its increase in incidence and prevalence in low- and middle-income countries (LIMIC) has potentially major implications for those high-income countries that characterize much of the developed world. Cardiovascular disease remains...
journal_title:European heart journal
pub_type: 杂志文章,评审
doi:10.1093/eurheartj/ehq030
更新日期:2010-03-01 00:00:00
abstract::Percutaneous excimer laser coronary angioplasty (ELCA) was performed in a first group of 20 patients with stable angina pectoris caused by significant coronary stenosis, and long-term follow-up was evaluated. Prototype 4 to 5.5 French multifibre catheters with 18-20 quartz fibres of 100 microns diameter, concentricall...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a060172
更新日期:1992-03-01 00:00:00
abstract::Spinal cord electrical stimulation is an alternative therapy for patients with chronic pain syndromes including angina. Although it has been shown to produce symptomatic relief and reduce ischaemia, doubts remain about its long-term safety. We report here for the first time the results of a follow-up study over a peri...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a060589
更新日期:1994-06-01 00:00:00