Cardiovascular Diseases — Biobehavioral Predictors of Coronary Angioplasty Outcome
Citation(s)
Gottdiener JS, Kop WJ, Hausner E, McCeney MK, Herrington D, Krantz DS Effects of mental stress on flow-mediated brachial arterial dilation and influence of behavioral factors and hypercholesterolemia in subjects without cardiovascular disease. Am J Cardiol. 2003 Sep 15;92(6):687-91.
Kop WJ, Ader DN Assessment and treatment of depression in coronary artery disease patients. Ital Heart J. 2001 Dec;2(12):890-4. Review.
Kop WJ, Gottdiener JS, Patterson SM, Krantz DS Relationship between left ventricular mass and hemodynamic responses to physical and mental stress. J Psychosom Res. 2000 Jan;48(1):79-88.
Kop WJ Chronic and acute psychological risk factors for clinical manifestations of coronary artery disease. Psychosom Med. 1999 Jul-Aug;61(4):476-87. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
