Introduction
Current definitions of phases of investigation and the role of the FDA in the conduct of clinical trials
Challenges in the conduct and interpretation of Phase II (pilot) randomized trials
The role of clinical nonfatal end points in cardiovascular Phase II/III clinical trials
Economic end points in Phase II trials
Select-drop designs in clinical trials
Sample size and interim analysis issues for dose selection
Equivalence and noninferiority trials
Design and interpretation of equivalence trials
Estimating the distribution of Quality-Adjusted Life with censored data
Chronic ischemic heart disease
Acute ischemic heart disease
Surrogate end points in cardiovascular disease trials
An FDA perspective on antiarrhythmic drugs in Phase II trials
The development of antiarrhythmic drugs
Current perspectives on the design of phase II trials of new drugs for the treatment of heart failure
Design of Phase II trials in congestive heart failure
Patient-specific dosing of IIb/IIIa antagonists during acute coronary syndromes: Rationale and design of the PARAGON B study
Medicaid, managed care, and the care of patients hospitalized for acute myocardial infarction
Statins: Effective antiatherosclerotic therapy
β-Blocker improvement in diastolic performance: The yin and yang of ventricular function changes
Neurohormonal activation in severe heart failure: Relations to patient death and the effect of treatment with flosequinan
β-Blockade therapy in chronic heart failure: Diastolic function and mitral regurgitation improvement by carvedilol
Randomized trial of candesartan cilexetil in the treatment of patients with congestive heart failure and a history of intolerance to angiotensin-converting enzyme inhibitors
Endothelial cell dysfunction correlates differentially with survival in primary and secondary pulmonary hypertension
Determinants of angiotensin-converting enzyme inhibitor prescription in severe heart failure with left ventricular systolic dysfunction: The EPICAL study
Reproducibility of neointima quantification with motorized intravascular ultrasound pullback in stented coronary arteries
Multivessel coronary stenting versus bypass surgery in patients with multivessel coronary artery disease and normal left ventricular function: Immediate and 2-year long-term follow-up
Role of intracoronary ultrasound after high-pressure stent implantation
Sex differences in coronary artery size assessed by intravascular ultrasound
Three-dimensional helical computed tomographic angiography in neonates and infants with complex congenital heart disease
Peripheral resistance vessel dysfunction in Marfan syndrome
Vasodilatation with felodipine in chronic asymptomatic aortic regurgitation
Detection of angiographically significant coronary artery disease with accelerated intermittent imaging after intravenous administration of ultrasound contrast material
Signal-averaged P-wave abnormalities and atrial size in patients with and without idiopathic paroxysmal atrial fibrillation
Long-term follow-up of patients requiring intravenous amiodarone to suppress hemodynamically destabilizing ventricular arrhythmias
Therapeutic heparin concentrations augment platelet reactivity: Implications for the pharmacologic assessment of the glycoprotein IIb/IIIa antagonist abciximab
Benefits of magnesium in acute myocardial infarction: Timing is crucial
Alcohol consumption and plasminogen activator inhibitor type 1: The National Heart, Lung, and Blood Institute Family Heart Study
Right ventricular function in patients with first inferior myocardial infarction: Assessment by tricuspid annular motion and tricuspid annular velocity
Impact of Doppler-derived left ventricular diastolic performance on exercise capacity in normal individuals
Aortic root dilatation among young competitive athletes: Echocardiographic screening of 1929 athletes between 15 and 34 years of age
Changes in lipoprotein(a) concentration after orthotopic heart transplantation
Benefits of lipid lowering on vascular reactivity in patients with coronary artery disease and average cholesterol levels: A mechanism for reducing clinical events?
Long-term estrogen replacement therapy is associated with improved exercise capacity in postmenopausal women without known coronary artery disease