NHLBI Type II Coronary Intervention Study - Full Text View

Purpose

To determine whether lowering of cholesterol with cholestyramine in a population with Type II hyperlipidemia led to a decreased rate of progression (a regression of coronary artery disease) as demonstrated by death, myocardial infarction, or progression of disease on angiography.

Condition	Intervention	Phase
Cardiovascular Diseases Coronary Disease Heart Diseases Hypercholesterolemia, Familial Myocardial Infarction Myocardial Ischemia	Drug: cholestyramine	Phase III

Genetics Home Reference related topics:

cholesteryl ester storage disease Farber lipogranulomatosis hypercholesterolemia long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency mitochondrial trifunctional protein deficiency primary carnitine deficiency

MedlinePlus related topics:

Cholesterol Heart Attack Heart Diseases

Drug Information available for:

Cholestyramine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:

November 1971

Detailed Description:

BACKGROUND:

There is overwhelming evidence that increased cholesterol levels are associated with increased risk of cardiovascular disease. This study examined whether lowering of cholesterol through drug therapy in people who had coronary artery disease as determined by angiography led to regression of the disease, again as indicated by angiography and reduction in mortality or nonfatal myocardial infarction. The study should be contrasted with the Coronary Primary Prevention Trial (CPPT), which determined whether lowering cholesterol through a combination of drug and diet therapy resulted in decreased cardiovascular mortality. It should be noted that patients in the CPPT did not have known preexisting coronary heart disease.

DESIGN NARRATIVE:

A randomized, double-blind trial, with single experimental and control groups. The experimental group received drug therapy (cholestyramine); the control group received placebo. Both groups received diet therapy. The endpoints were a significant difference in the progression of coronary disease as shown by angiography or a significant difference in new myocardial infarction or death. Patients were followed under therapy for at least 5 years.

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Men and women with angiographically demonstrated coronary artery disease.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000594

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


Investigator:	John Brensike	Cardiology Branch, NHLBI

More Information

Publications:

Borer JS, Brensike JF, Redwood DR, Itscoitz SB, Passamani ER, Stone NJ, Richardson JM, Levy RI, Epstein SE. Limitations of the electrocardiographic response to exercise in predicting coronary-artery disease. N Engl J Med. 1975 Aug 21;293(8):367-71.

Belmaker RH, Pollin W, Jenkins CD, Brensike J. Coronary prone behavior pattern in a sample of type II hypercholesteremic patients. J Psychosom Res. 1976;20(6):591-4. No abstract available.

Aldrich RF, Brensike JF, Battaglini JW, Richardson JM, Loh IK, Stone NJ, Passamani ER, Ackerstein H, Seningen R, Borer JS, Levy RI, Epstein SE. Coronary calcifications in the detection of coronary artery disease and comparison with electrocardiographic exercise testing. Results from the National Heart, Lung, and Blood Institute's type II coronary intervention study. Circulation. 1979 Jun;59(6):1113-24. No abstract available.

Brensike JF, Kelsey SF, Passamani ER, Fisher MR, Richardson JM, Loh IK, Stone NJ, Aldrich RF, Battaglini JW, Moriarty DJ, Myrianthopoulos MB, Detre KM, Epstein SE, Levy RI. National Heart, Lung, and Blood Institute type II Coronary Intervention Study: design, methods, and baseline characteristics. Control Clin Trials. 1982 Jun;3(2):91-111.

Brensike JF, Levy RI, Kelsey SF, Passamani ER, Richardson JM, Loh IK, Stone NJ, Aldrich RF, Battaglini JW, Moriarty DJ, et al. Effects of therapy with cholestyramine on progression of coronary arteriosclerosis: results of the NHLBI Type II Coronary Intervention Study. Circulation. 1984 Feb;69(2):313-24.

Levy RI, Brensike JF, Epstein SE, Kelsey SF, Passamani ER, Richardson JM, Loh IK, Stone NJ, Aldrich RF, Battaglini JW, et al. The influence of changes in lipid values induced by cholestyramine and diet on progression of coronary artery disease: results of NHLBI Type II Coronary Intervention Study. Circulation. 1984 Feb;69(2):325-37.

Brown BG, Lin JT, Kelsey S, Passamani ER, Levy RI, Dodge HT, Detre KM. Progression of coronary atherosclerosis in patients with probable familial hypercholesterolemia. Quantitative arteriographic assessment of patients in NHLBI type II study. Arteriosclerosis. 1989 Jan-Feb;9(1 Suppl):I81-90.

Study ID Numbers:	400
First Received:	October 27, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000594
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Lipid Metabolism, Inborn Errors

Cholestyramine

Heart Diseases

Hyperlipidemias

Metabolic Diseases

Myocardial Ischemia

Hyperlipoproteinemia Type II

Vascular Diseases

Ischemia

Coronary Disease

Metabolism, Inborn Errors

Necrosis

Genetic Diseases, Inborn

Metabolic disorder

Infarction

Myocardial Infarction

Hypercholesterolemia

Hyperlipoproteinemias

Dyslipidemias

Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites

Pathologic Processes

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Antilipemic Agents

Cardiovascular Diseases

Anticholesteremic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000594