National heart, lung, and blood institute type II coronary intervention study: Design, methods, and baseline characteristics

John F. Brensike; Sheryl F. Kelsey; Eugene R. Passamani; Marian R. Fisher; John M. Richardson; Irving K. Loh; Neil J. Stone; Robert F. Aldrich; James W. Battaglini; Daniel J. Moriarty; Majorie B. Myrianthopoulos; Katherine M. Detre; Stephen E. Epstein; Robert I. Levy

doi:10.1016/0197-2456(82)90038-1

National heart, lung, and blood institute type II coronary intervention study: Design, methods, and baseline characteristics

John F. Brensike, Sheryl F. Kelsey^*, Eugene R. Passamani, Marian R. Fisher, John M. Richardson, Irving K. Loh, Neil J. Stone, Robert F. Aldrich, James W. Battaglini, Daniel J. Moriarty, Majorie B. Myrianthopoulos, Katherine M. Detre, Stephen E. Epstein, Robert I. Levy

^*Corresponding author for this work

Medicine, Cardiology Division

Research output: Contribution to journal › Article › peer-review

28 Scopus citations

Abstract

The Type II Coronary Intervention Study (Type II Study) is a double-blind, randomized, placebo-controlled clinical trial conducted by the Division of Intramural Research of the National Heart, Lung, and Blood Institute of Bethesda, Maryland. The study was designed to evaluate the 5-year treatment effect of cholestyramine on low density lipoprotein (LDL) cholesterol and on lesions in the coronary arteries. One hundred forty-three patients with Type II hyperlipoproteinemia (elevated LDL cholesterol) and coronary artery disease (CAD) were entered into the study between 1972 and 1976. Patients were stratified by sex and extent of coronary disease as defined angiographically and were randomly allocated to a daily dosage of 24 g cholestyramine and diet (treatment group) or placebo and diet (control group). Changes in the coronary arteries were evaluated by sequential coronary angiography carried out before and after five years of treatment. This report describes the trial design and baseline characteristics of the study patients.

Original language	English (US)
Pages (from-to)	91-111
Number of pages	21
Journal	Controlled Clinical Trials
Volume	3
Issue number	2
DOIs	https://doi.org/10.1016/0197-2456(82)90038-1
State	Published - Jun 1982

Keywords

clinical trial
coronary angiography
progression and regression of coronary artery disease
treatment of Type II hyperlipoproteinemia

ASJC Scopus subject areas

Pharmacology

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Brensike, J. F., Kelsey, S. F., Passamani, E. R., Fisher, M. R., Richardson, J. M., Loh, I. K., Stone, N. J., Aldrich, R. F., Battaglini, J. W., Moriarty, D. J., Myrianthopoulos, M. B., Detre, K. M., Epstein, S. E., & Levy, R. I. (1982). National heart, lung, and blood institute type II coronary intervention study: Design, methods, and baseline characteristics. Controlled Clinical Trials, 3(2), 91-111. https://doi.org/10.1016/0197-2456(82)90038-1

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title = "National heart, lung, and blood institute type II coronary intervention study: Design, methods, and baseline characteristics",

abstract = "The Type II Coronary Intervention Study (Type II Study) is a double-blind, randomized, placebo-controlled clinical trial conducted by the Division of Intramural Research of the National Heart, Lung, and Blood Institute of Bethesda, Maryland. The study was designed to evaluate the 5-year treatment effect of cholestyramine on low density lipoprotein (LDL) cholesterol and on lesions in the coronary arteries. One hundred forty-three patients with Type II hyperlipoproteinemia (elevated LDL cholesterol) and coronary artery disease (CAD) were entered into the study between 1972 and 1976. Patients were stratified by sex and extent of coronary disease as defined angiographically and were randomly allocated to a daily dosage of 24 g cholestyramine and diet (treatment group) or placebo and diet (control group). Changes in the coronary arteries were evaluated by sequential coronary angiography carried out before and after five years of treatment. This report describes the trial design and baseline characteristics of the study patients.",

keywords = "clinical trial, coronary angiography, progression and regression of coronary artery disease, treatment of Type II hyperlipoproteinemia",

author = "Brensike, {John F.} and Kelsey, {Sheryl F.} and Passamani, {Eugene R.} and Fisher, {Marian R.} and Richardson, {John M.} and Loh, {Irving K.} and Stone, {Neil J.} and Aldrich, {Robert F.} and Battaglini, {James W.} and Moriarty, {Daniel J.} and Myrianthopoulos, {Majorie B.} and Detre, {Katherine M.} and Epstein, {Stephen E.} and Levy, {Robert I.}",

note = "Funding Information: ·Supported in part by the NHLBI, contract number: NOl-HI-72947",

year = "1982",

month = jun,

doi = "10.1016/0197-2456(82)90038-1",

language = "English (US)",

volume = "3",

pages = "91--111",

journal = "Controlled Clinical Trials",

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publisher = "Elsevier BV",

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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 1982, 'National heart, lung, and blood institute type II coronary intervention study: Design, methods, and baseline characteristics', Controlled Clinical Trials, vol. 3, no. 2, pp. 91-111. https://doi.org/10.1016/0197-2456(82)90038-1

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AU - Brensike, John F.

AU - Kelsey, Sheryl F.

AU - Passamani, Eugene R.

AU - Fisher, Marian R.

AU - Richardson, John M.

AU - Loh, Irving K.

AU - Stone, Neil J.

AU - Aldrich, Robert F.

AU - Battaglini, James W.

AU - Moriarty, Daniel J.

AU - Myrianthopoulos, Majorie B.

AU - Detre, Katherine M.

AU - Epstein, Stephen E.

AU - Levy, Robert I.

N1 - Funding Information: ·Supported in part by the NHLBI, contract number: NOl-HI-72947

PY - 1982/6

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AB - The Type II Coronary Intervention Study (Type II Study) is a double-blind, randomized, placebo-controlled clinical trial conducted by the Division of Intramural Research of the National Heart, Lung, and Blood Institute of Bethesda, Maryland. The study was designed to evaluate the 5-year treatment effect of cholestyramine on low density lipoprotein (LDL) cholesterol and on lesions in the coronary arteries. One hundred forty-three patients with Type II hyperlipoproteinemia (elevated LDL cholesterol) and coronary artery disease (CAD) were entered into the study between 1972 and 1976. Patients were stratified by sex and extent of coronary disease as defined angiographically and were randomly allocated to a daily dosage of 24 g cholestyramine and diet (treatment group) or placebo and diet (control group). Changes in the coronary arteries were evaluated by sequential coronary angiography carried out before and after five years of treatment. This report describes the trial design and baseline characteristics of the study patients.

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KW - progression and regression of coronary artery disease

KW - treatment of Type II hyperlipoproteinemia

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National heart, lung, and blood institute type II coronary intervention study: Design, methods, and baseline characteristics

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