Trials

http://www.trialsjournal.com/

List of Papers (Total 4,046)

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 failure. In comparison with ACEi, ARBs are better tolerated and have similar effects on haemodynamics, neurohormones and exercise capacity. Early studies have suggested that ...

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 history and factors associated with disease progression. Because every participant can reach an end-point, sufficient power can be attained with much smaller numbers of subjects ...

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 deep venous thrombosis and pulmonary embolism. Randomized studies have shown that LMWHs are as effective as unfractionated heparin in the prevention of recurrent venous ...

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 difference in blood pressure was achieved, the results for myocardial infarction were roughly half that expected. This suggested that adverse drug effects of diuretics and ...

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 aid in the prevention, diagnosis and treatment of the majority of diseases. Despite the high level of publicity for research discoveries, clinicians have had difficulty in ...

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

Synopsis Background 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 percutaneous coronary interventions (PCIs) and coronary artery bypass surgery. The myocardial NHE plays a critical role in mediating the progression of ...

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 use of vitamin E improve prognosis. In contrast, treatment of coronary-artery disease with angiotensin-converting-enzyme (ACE) inhibitors reduced coronary-event rates and ...

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 transient stimulus to lumen renarrowing, that this process is almost complete at 6 months and that a certain degree of neointima regression is also possible after this time. Clinical ...

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 nationwide mandatory reporting with public release of performance data to voluntary reporting and quality-assurance efforts that protect the confidentiality of error-related data. ...

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 corrected TIMI frame count (CTFC) is a simple, more objective continuous variable index of coronary blood flow that can be broadly and inexpensively applied. This measure of the ...

Debate: When should we intervene in unstable angina - Time for an old look?

Current treatment modalities for patients with acute coronary syndromes center on early diagnosis, risk stratification and, increasingly, early treatment including invasive approaches. The appropriate timing of these invasive modalities in the context of the overall treatment program remains an area of controversy. Specifically, studies in the past recommended a period of medical ...

Genetic counselling for hypertrophic cardiomyopathy: are we ready for it?

Hypertrophic cardiomyopathy (HCM) is a dominant genetic disorder of the myocardium associated with dysfunctional contractile proteins. The major risk of HCM is sudden cardiac death, which may occur even in asymptomatic carriers. Causes are highly heterogeneous. Over 140 different mutations in nine sarcomeric genes have been described to date. The majority of cases (80% or more) may ...

Current Controlled Trials: an opportunity to help improve the quality of clinical research

Some problems with the quality of controlled clinical trials can be addressed by following these procedures: registering all trials at inception; using systematic reviews to inform the design of new studies; posting and obtaining feedback on preprints; reporting all well conducted trials, regardless of their results; reducing biased and inefficient assessment of reports submitted ...

Clinical trials in developing countries: Discussions at the '9th International Symposium on Long Term Clinical Trials', London, UK, 19-20 June 2000

This symposium provided a useful forum for the discussion of issues relating to the design and conduct of clinical trials. There is a need for greater awareness of the complexity of modern day trials, in which a host of statistical, logistical, regulatory and ethical issues are involved. Issues discussed ranged from the effect of sample size on the outcome, and subgroup analysis, ...

Debate: A subversive view of subsets - a dissident clinician's opinion

Clinical trialists and statisticians are very wary of subgroup analysis, for good reasons. Clinicians have to deal with situations in which subgroups of patients differ widely from one another in their prognosis and response to treatment. Few trials are large enough to demonstrate convincingly these differences in outcome, but often provide suggestive evidence. Should we ignore ...

Debate: Subgroup analyses in clinical trials: fun to look at - but don't believe them!

Analysis of subgroup results in a clinical trial is surprisingly unreliable, even in a large trial. This is the result of a combination of reduced statistical power, increased variance and the play of chance. Reliance on such analyses is likely to be more erroneous, and hence harmful, than application of the overall proportional (or relative) result in the whole trial to the ...

Implications of recent hypertension trials for the generalist physician: whom do we treat, and how?

The publication of the results of the Swedish Trial in Old Patients with Hypertension-2 (STOP-2) and the termination of the doxazocin arm of the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack (ALLHAT) study again raise the question of whether all antihypertensives deliver equal cardiovascular outcome benefits. Data from research on congestive heart failure ...

Noninferiority trials

Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin. These trials have a number of inherent weaknesses that superiority trials do not: no internal demonstration of assay sensitivity, no single conservative analysis approach, lack of protection from bias by blinding, and difficulty ...