Bielak LF, Rumberger JA, Sheedy PF 2nd, Schwartz RS, Peyser PA Probabilistic model for prediction of angiographically defined obstructive coronary artery disease using electron beam computed tomography calcium score strata. Circulation. 2000 Jul 25;102(4):380-5.
Bielak LF, Sheedy PF 2nd, Peyser PA Coronary artery calcification measured at electron-beam CT: agreement in dual scan runs and change over time. Radiology. 2001 Jan;218(1):224-9.
Kardia SL, Haviland MB, Ferrell RE, Sing CF The relationship between risk factor levels and presence of coronary artery calcification is dependent on apolipoprotein E genotype. Arterioscler Thromb Vasc Biol. 1999 Feb;19(2):427-35.
Kardia SL, Modell SM, Peyser PA Family-centered approaches to understanding and preventing coronary heart disease. Am J Prev Med. 2003 Feb;24(2):143-51. Review.
Kaufmann RB, Peyser PA, Sheedy PF, Rumberger JA, Schwartz RS Quantification of coronary artery calcium by electron beam computed tomography for determination of severity of angiographic coronary artery disease in younger patients. J Am Coll Cardiol. 1995 Mar 1;25(3):626-32.
Rumberger JA, Behrenbeck T, Breen JF, Sheedy PF 2nd Coronary calcification by electron beam computed tomography and obstructive coronary artery disease: a model for costs and effectiveness of diagnosis as compared with conventional cardiac testing methods. J Am Coll Cardiol. 1999 Feb;33(2):453-62.
Rumberger JA, Sheedy PF 3rd, Breen JF, Schwartz RS Coronary calcium, as determined by electron beam computed tomography, and coronary disease on arteriogram. Effect of patient's sex on diagnosis. Circulation. 1995 Mar 1;91(5):1363-7.
Rumberger JA, Sheedy PF, Breen JF, Schwartz RS Electron beam computed tomographic coronary calcium score cutpoints and severity of associated angiographic lumen stenosis. J Am Coll Cardiol. 1997 Jun;29(7):1542-8.
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.
