Completed

Atherosclerosis in the Coronary and Carotid Arteries: Correlations Between Coronary IVUS, Carotid Ultrasound, and Carotid MRI

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What is being collected

Data Collection

Who is being recruted

Arterial Occlusive Diseases
+5

+ Arteriosclerosis
+ Cardiovascular Diseases
See all eligibility criteria
How is the trial designed

Observational
Study Start: April 2004
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2004Actual date on which the first participant was enrolled.

Under the general hypothesis that atherosclerosis is a systemic disease; the purpose of this protocol is to compare coronary artery atherosclerotic abnormalities with carotid artery abnormalities. This is an NHLBI sponsored sub study to the Pfizer sponsored trial comparing atorvastatin or the combination of atorvastatin/CETP inhibitor as treatments for patients with coronary heart disease. The primary study is a multicenter, randomized, double blind, active-controlled study which uses intracoronary ultrasound to measure coronary plaque volume during the course of treatment. The scientific value of the NHLBI sub study will be the comparison of atherosclerotic abnormalities in two different vascular beds, the coronary artery and the carotid arteries. This study will examine correlations between invasive coronary measurements by intravascular ultrasound (IVUS), with 2-dimensional measurements of wall thickness by carotid intimal medial wall thickness (IMT), and with 3-dimensional measurements of carotid wall volume by MRI and 3D ultrasound. Secondary analysis will probe whether carotid plaque characteristics can predict atheroma regression. Secondary analysis will also assess the ability of noninvasive carotid measures to predict the degree of coronary regression determined in the coronary arteries by IVUS. It is important to note that the NHLBI study design remains blinded to the treatment group a subject is enrolled in since the sample size for a single center study is too small to detect the conservatively estimated additional benefit of combination atorvastatin/CETP inhibitor treatment over the already effective atorvastatin alone. Thus, the NHLBI sub study is primarily a pathophysiological study correlating carotid and coronary atherosclerotic changes as well as a technological comparison of IVU, carotid IMT, and carotid vessel wall volume by MRI. If successful, this study could provide the framework for following treatment trials of this nature with noninvasive tools, either ultrasound or MRI, in place of the accurate but invasive IVUS.

Official TitleAtherosclerosis in the Coronary and Carotid Arteries: Correlations Between Coronary IVUS, Carotid Ultrasound, and Carotid MRI 
NCT00080587
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
125 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Heart Diseases
Vascular Diseases
Myocardial Ischemia
Atherosclerosis
Criteria

INCLUSION CRITERIA Patients will be a subset of patients participating in the multicenter IVUS protocol. Willingness to travel to the NIH to participate in the NHLBI MRI/IMT study. EXCLUSION CRITERIA Pacemaker Defibrillator Brain aneurysm clips Implanted active medical devices (neural stimulators, cochlear implants, insulin pumps, etc.) Severe claustrophobia Allergy to gadolinium based contrast agents (only excludes the gadolinium portion of the test)



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
National Heart, Lung and Blood Institute (NHLBI)Bethesda, United StatesSee the location

CompletedOne Study Center
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