Articles

Treating patients with low high-density lipoprotein cholesterol: choices, issues and opportunities

Three clinical trials have recently focused on the benefits of lipid-regulating therapy in populations with normocholesterolaemia and low high-density lipoprotein (HDL)-cholesterol. Two secondary prevention st...

Authors: Gerald F Watts

A review of clinical trials in dietary interventions to decrease the incidence of coronary artery disease

Of the associations between dietary elements and coronary artery disease (CAD), the greatest body of evidence deals with the beneficial effect of reducing the dietary intake of saturated fatty acids and choles...

Authors: Helena Gylling and Tatu A Miettinen

Selected highlights from the 50^th Annual Scientific Session of the American College of Cardiology, Orlando, USA, 18-21 March 2001

The recent scientific session of the American College of Cardiology (ACC), held in Orlando, provided a forum for ongoing cardiovascular clinical trials from around the world. The high point was clearly the fir...

Authors: Joanna Lyford

Implications of troponin testing in clinical medicine

During the past decade considerable research has been conducted into the use of cardiac troponins, their diagnostic capability and their potential to allow risk stratification in patients with acute chest pain...

Authors: Britta U Goldmann, Robert H Christenson, Christian W Hamm, Thomas Meinertz and E Magnus Ohman

New insights into the effects on blood pressure of diets low in salt and high in fruits and vegetables and low-fat dairy products

Results from the recent Dietary Approaches to Stop Hypertension (DASH)-Sodium trial provide the latest evidence concerning the effects of dietary patterns and sodium intake on blood pressure. Participants ate ...

Authors: William M Vollmer, Frank M Sacks and Laura P Svetkey

Ablation of atrial fibrillation: a procedure come of age?

Various approaches for catheter ablation of focal initiators of atrial fibrillation or the substrate for maintaining atrial fibrillation have evolved over the past 5 years. Despite these advances, there are st...

Authors: J Marcus Wharton

No effects on myocardial ischaemia in patients with stable ischaemic heart disease after treatment with ramipril for 6 months

To assess the effects of a 6-month angiotensin-converting enzyme (ACE) inhibitor intervention on myocardial ischaemia.

Authors: Ronnie Willenheimer, Steen Juul-Möller, Lennart Forslund and Leif Erhardt

Debate: does it matter how you lower blood pressure?

The evidence base for drug treatment of hypertension is strong. Early trials using thiazide diuretics suggested a shortfall in prevention of coronary heart disease. The superiority of newer drugs has been wide...

Authors: Gordon T McInnes

Debate: "How low should LDL cholesterol be lowered for optimum prevention of vascular disease?" Viewpoint: "Below 100 mg/dl"

Arteriosclerotic vascular disease manifests as heart disease, stroke, aortic aneurysms, and peripheral vascular disease, and is a growing problem world-wide. The preventive efforts made so far have demonstrate...

Authors: W Virgil Brown

Are there fundamental deficiencies in the megatrial methodology?

Authors: Desmond Julian and Curt Furberg

New immunosuppressive drugs in heart transplantation

Only a few randomized clinical trials have been performed so far in heart transplant recipients, mainly because of the relatively small number of heart transplants performed worldwide each year. The main focus...

Authors: Maria Rosa Costanzo

Experience collecting interim data on mortality: an example from the RALES study

The Randomized Aldactone Evaluation Study (RALES) randomized 822 patients to receive 25 mg spironolactone daily and 841 to receive placebo. The primary endpoint was death from all causes. Randomization began o...

Authors: Janet Wittes, Jolie Palensky, Debra Asner, Desmond Julian, Jean-Pierre Boissel, Curt D Furberg, Henri Kulbertus, Stuart Pocock and Barbara Roniker

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial

Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of β-adrenergic ...

Authors: Eric J Eichhorn and Michael R Bristow

The Proliferation REduction with Vascular ENergy Trial (PREVENT)

PREVENT was the first prospective, randomized placebo-controlled study of intracoronary beta radiotherapy with ³²P. A total of 105 patients with de novo or restenotic lesions, treated by stenting or balloon angio...

Authors: Albert E Raizner and Grzegorz L Kaluza

Use of diffusion and perfusion magnetic resonance imaging as a tool in acute stroke clinical trials

In light of the slow progress in developing effective therapies for ischemic stroke, magnetic resonance imaging techniques have emerged as new tools in stroke clinical trials. Rapid imaging with magnetic reson...

Authors: Steven Warach

The current status of primary prevention in coronary heart disease

During the second part of the twentieth century, research advances caused a substantial decline in the rate of coronary heart disease. The decline lasted from the mid-1960s until the early 1990s and occurred p...

Authors: Cornel Pater

Debate: "How low should LDL cholesterol be lowered?" Viewpoint: "It doesn't need to be very low"

The importance of low-density lipoprotein (LDL) control in the management of patients at high risk of cardiovascular events is unquestionable. The major statin trials have shown that the benefits of LDL loweri...

Authors: Sergio Fazio and MacRae F Linton

Fundamental deficiencies in the megatrial methodology

The fundamental methodological deficiency of megatrials is deliberate reduction of experimental control in order to maximize recruitment and compliance of subjects. Hence, typical megatrials recruit pathologic...

Authors: Bruce G Charlton

Design of the Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial [ISRCTN19943732]

The Intravenous Magnesium Efficacy in Acute Stroke (IMAGES) trial is a multicentre,randomised, placebo-controlled trial of magnesium sulphate (MgSO₄) funded by the UK Medical Research Council. When complete, it w...

Authors: Andrew Bradford and Kennedy Lees

What is the optimal prophylaxis for treatment of cardiac allograft vasculopathy?

Coronary artery disease in the transplanted heart, also known as cardiac allograft vasculopathy (CAV), is one of the major causes of mortality late after transplantation. It affects up to 50% of all heart tran...

Authors: Jon Kobashigawa

Debate: Should the elderly receive thrombolytic therapy or primary angioplasty?

Thrombolysis and primary angioplasty are both recommended reperfusion strategies for elderly patients presenting with myocardial infarction (MI). Primary angioplasty is most beneficial in high-risk patients. W...

Authors: Harvey D White

Debate: Should the elderly receive thrombolytic therapy, or primary angioplasty, for acute myocardial infarction? The case for primary angioplasty

As the population ages the number of elderly patients presenting with acute myocardial infarction (AMI) will continue to increase. There has been no head-to-head trial of thrombolytic therapy versus primary pe...

Authors: Vincent S DeGeare and Cindy L Grines

Debate: The potential role of estrogen in the prevention of heart disease in women after menopause

Large numbers of observational studies have described a decrease in the incidence of cardiovascular disease in women taking hormone replacement therapy (HRT). The potential mechanisms for this effect are numer...

Authors: Rebecca R Johnson and Mary E Sweeney

Are statins anti-inflammatory?

Large scale clinical trials demonstrate significant reductions in cardiovascular event rates with statin therapy. The observed benefit of statin therapy, however, may be larger in these trials than that expect...

Authors: Gavin J Blake and Paul M Ridker

Is clopidogrel superior to aspirin in secondary prevention of vascular disease?

The cornerstone in clinical evidence of the relative efficacy of thienopyridines (clopidogrel, ticlopidine) versus aspirin in the secondary prevention of vascular disease is the Clopidogrel versus Aspirin in P...

Authors: Ale Algra and Jan van Gijn

Design of a randomized controlled trial of comprehensive rehabilitation in patients with myocardial infarction, stabilized acute coronary syndrome, percutaneous transluminal coronary angioplasty or coronary artery bypass grafting: Akershus Comprehensive Cardiac Rehabilitation Trial (the CORE Study)

1. To assess the long-term effectiveness of a comprehensive cardiac rehabilitation programme on quality of life and survival in patients with a large spectrum of cardiovascular diseases (myocardial infarction,...

Authors: Cornel Pater, Carl Ditlef Jacobsen, Arnfinn Rollag, Leiv Sandvik, Jan Erikssen and Else Karin Kogstad

Exercise training in heart failure

Chronic heart failure (CHF) is a common condition with a poor prognosis. It is associated with poor exercise tolerance and debilitating symptoms. These symptoms appear to be associated with pathophysiological ...

Authors: Andrew JS Coats

Debate: The potential role of estrogen in the prevention of heart disease in women after menopause

The observational studies of hormone users are compromised by systematic biases that lead to an overestimation of benefit and an underestimation of risk. Studies of mechanism could support either benefit or ha...

Authors: Jacques E Rossouw

β-Adrenergic gene therapy for cardiovascular disease

Gene therapy using in vivo recombinant adenovirus-mediated gene transfer is an effective technique that offers great potential to improve existing drug treatments for the complex cardiovascular diseases of heart ...

Authors: Andrea D Eckhart and Walter J Koch

An essential guide to the literature

Authors: William J Penny and John P Bourke

Gene therapy for lipid disorders

Lipid disorders are associated with atherosclerotic vascular disease, and therapy is associated with a substantial reduction in cardiovascular events. Current approaches to the treatment of lipid disorders are...

Authors: Masa-aki Kawashiri and Daniel J Rader

Medical therapy versus interventional therapy in hypertropic obstructive cardiomyopathy

Medical treatment in symptomatic patients with hypertrophic obstructive cardiomyopathy aims to reduce the outflow tract gradients, and to improve diastolic dysfunction and rhythm disorders. Surgical myectomy i...

Authors: Hubert Seggewiss

Pacing in congestive heart failure

Despite the major advances in medical drug therapy, heart failure remains a syndrome associated with high mortality and morbidity. Biventricular or left ventricular (LV) short atrioventricular (AV) delay pacin...

Authors: Jayne A Morris-Thurgood and Michael P Frenneaux

Debate: Do all patients with heart failure require implantable defibrillators to prevent sudden death?

Sudden death is a major cause of mortality in patients with ventricular dysfunction. The highest risk occurs among patients with less severe functional impairment. Current methods of risk stratification are in...

Authors: Henry H Hsia, Mariell L Jessup and Francis E Marchlinski

Debate: Do all patients with heart failure require automatic implantable defibrillators for the prevention of sudden death?

Recent clinical trials indicate that approximately two-thirds of patients in New York Heart Association (NYHA) class II and III, who comprise almost 90% of patients with heart failure, die suddenly. Patients i...

Authors: Sidney Goldstein

Debate: Do all patients with heart failure require implantable defibrillators to prevent sudden death?

Authors: Jacobus Lubsen

Clinical applicability of molecular biology: the case of the long QT syndrome

The clinical applicability of molecular cardiology has been questioned at length and by many clinical investigators. The congenital long QT syndrome (LQTS) provides an excellent example of how tight the relati...

Authors: Peter J Schwartz

Results of the Ticlid or Plavix Post-Stents (TOPPS) trial: do they justify the switch from ticlopidine to clopidogrel after coronary stent placement?

In the Ticlid or Plavix Post-Stents (TOPPS) trial, 1016 patients undergoing successful coronary stent placement were randomized to receive aspirin and either ticlopidine or clopidogrel. In this trial, the dosa...

Authors: Peter B Berger

Debate: The slippery slope of surrogate outcomes

Surrogate outcomes are frequently used in cardiovascular disease research. A concern is that changes in surrogate markers may not reflect changes in disease outcomes. Two recent clinical trials (Heart and Estr...

Authors: Ralph B D'Agostino Jr

Angiotensin receptor blockers in heart failure after the ELITE II trial

Specific blockers of the angiotensin type1 receptor, angiotensin receptor blockers (ARBs), have been introduced as an alternative to angiotensin-converting enzyme inhibitors (ACEi) for the treatment of heart f...

Authors: Ronnie Willenheimer

Debate: Are surrogate end-point studies worth the effort?

Surrogate end-points of cardiovascular disease can provide useful information in cross-sectional, prospective and interventional studies. They provide information on association with risk factors, natural hist...

Authors: Jonathan Valabhji and Robert S Elkeles

Low-molecular-weight heparins in the treatment of venous thromboembolism

Venous thromboembolism is a common disease that is associated with considerable morbidity if left untreated. Recently, low-molecular-weight heparins (LMWHs) have been evaluated for use in acute treatment of de...

Authors: Walter Ageno and Menno V Huisman

Debate: Does it matter how you lower blood pressure?

Whether it matters how pressure is lowered has been debated since antihypertensive drugs proved to prevent cardiovascular events. However, in clinical trials, while the stroke benefit predicted by a given diff...

Authors: Michael H Alderman

Current Controlled Trials in Cardiovascular Medicine: a new journal for a new age (http://cvm.controlled-trials.com)

Authors: Curt Furberg and Bertram Pitt

Use of intravenous antiarrhythmics to identify concealed Brugada syndrome

Cardiology has recently witnessed the production of an overwhelming amount of data through the advances made in genetics and molecular biology research. Understanding of genetics has tremendous potential to ai...

Authors: Ramon Brugada

Design of a trial evaluating myocardial cell protection with cariporide, an inhibitor of the transmembrane sodium-hydrogen exchanger: the Guard During Ischemia Against Necrosis (GUARDIAN) trial

Direct myocardial cell protection in patients with unstable angina or evolving myocardial infarction (MI) could prevent cell necrosis or reduce its extent, and minimize the risk of MI and death associated with...

Authors: Pierre Theroux, Bernard R Chaitman, Leif Erhardt, Andreas Jessel, Thomas Meinertz, Wolf-Ulrich Nickel, John S Schroeder, Gianni Tognoni, Harvey White and James T Willerson

Why do antioxidants fail to provide clinical benefit?

The results of recent randomized trials to test the influence of antioxidants on coronary-event rates and prognosis in patients with coronary-artery disease were disappointing. In none of these studies did the...

Authors: Ascan Warnholtz and Thomas Münzel

Long-term outcome after coronary stenting

The present review assesses the data on long-term outcome after coronary stenting. Histological, angiographical and intravascular imaging data have shown that the insertion of stents constitutes only a transie...

Authors: Adnan Kastrati, Donald Hall and Albert Schömig

Medical errors: how the US Government is addressing the problem

November's Institute of Medicine (IOM) report on medical errors has sparked debate among US health policy makers as to the appropriate response to the problem. Proposals range from the implementation of nation...

Authors: Kevin A Schulman and John J Kim

Importance of the TIMI frame count: implications for future trials

Although the TIMI (Thrombolysis In Myocardial Infarction) flow grade classification scheme is widely used to assess angiographic outcomes, it is limited by poor reproducibility and its categoric nature. The co...

Authors: Mark A Appleby, Andrew D Michaels, Michael Chen and C Gibson Michael