Odell A, Grip L, Hallberg LR Restenosis after percutaneous coronary intervention (PCI): experiences from the patients' perspective. Eur J Cardiovasc Nurs. 2006 Jun;5(2):150-7. Epub 2005 Nov 16.
Stables RH Design of the 'Stent or Surgery' trial (SoS): a randomized controlled trial to compare coronary artery bypass grafting with percutaneous transluminal coronary angioplasty and primary stent implantation in patients with multi-vessel coronary artery disease. Semin Interv Cardiol. 1999 Dec;4(4):201-7.
Sullivan M, Karlsson J The Swedish SF-36 Health Survey III. Evaluation of criterion-based validity: results from normative population. J Clin Epidemiol. 1998 Nov;51(11):1105-13.
Waters DD Medical therapy versus revascularization: the atorvastatin versus revascularization treatment AVERT trial. Can J Cardiol. 2000 Jan;16 Suppl A:11A-3A.
What Are the Expectations for Future Examination and Treatment in Patients Undergoing Evaluation and Treatment of Coronary Heart Disease?
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.
