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National Heart, Lung, and Blood Institute type II Coronary Intervention Study: design, methods, and baseline
Insights
This study investigated cholestyramine
Area of Science:
- Cardiovascular Medicine
- Clinical Trials
- Pharmacology
Background:
- Coronary artery disease (CAD) and Type II hyperlipoproteinemia are significant cardiovascular risk factors.
- Elevated low-density lipoprotein (LDL) cholesterol contributes to atherosclerosis and CAD progression.
- Effective lipid-lowering therapies are crucial for managing coronary artery disease.
Purpose of the Study:
- To evaluate the 5-year efficacy of cholestyramine in reducing LDL cholesterol.
- To assess the impact of cholestyramine on coronary artery lesions in patients with CAD.
- To provide a comprehensive report on the trial design and baseline characteristics of participants.
Main Methods:
- A double-blind, randomized, placebo-controlled clinical trial involving 143 patients.
- Patients with Type II hyperlipoproteinemia and CAD were stratified by sex and disease extent.
- Intervention involved daily cholestyramine (24g) plus diet versus placebo plus diet for five years.
- Coronary angiography was used for sequential evaluation of coronary artery changes.
Main Results:
- The report focuses on trial design and baseline characteristics, not 5-year outcomes.
- Baseline data collection was performed before treatment initiation.
- Patient stratification ensured balanced groups for treatment comparison.
Conclusions:
- The Type II Coronary Intervention Study was designed to assess cholestyramine's long-term effects on lipid levels and coronary atherosclerosis.
- This report serves as a foundational document detailing the study's methodology and patient cohort.
- Further reports will detail the 5-year treatment effects on LDL cholesterol and coronary lesions.
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.