NCT00080587

Brief Summary

This study will compare changes in atherosclerotic plaque in the coronary arteries (vessels on the surface of the heart that supply blood to the heart) with changes in the carotid arteries (vessels in the neck that supply blood to the brain) in patients enrolled in a Pfizer-sponsored treatment trial for coronary artery disease. Atherosclerosis is a buildup of fatty deposits (plaque) in arteries that can lead to blockage of the vessel, possibly resulting in heart attack or stroke. A major question in cardiovascular disease is how closely atherosclerotic changes in the coronary arteries correlate with changes in the carotid artery that occur with treatment. substudy of a Pfizer. Patients enrolled in the Pfizer trial comparing the effectiveness of the drug atorvastatin with a combination of atorvastatin and CETP inhibitor (a drug to increase HDL cholesterol levels) may be eligible for this substudy. Participants undergo magnetic resonance imaging (MRI) and ultrasound of the carotid arteries to measure the thickness of the vessels. The results are then compared with the coronary artery images obtained as part of the patient's evaluation for the Pfizer trial. MRI MRI scans use a powerful magnet with an advanced computer system and radio waves to produce accurate, detailed pictures of organs and tissues. During the scan the patient lies on a table in a narrow cylinder containing a magnetic field, wearing earplugs to muffle loud noises that occur with electrical switching of the magnetic fields. A medicine called gadolinium contrast may be injected into a vein during part of the scan to brighten the images. The scan takes about 30 to 90 minutes. An electrocardiogram (ECG) is done during the scan to monitor the heart's electrical activity. Patients who agree to undergo another MRI test are also imaged in a scanner that uses a stronger (3 Tesla) magnet. Ultrasound An echocardiogram (ultrasound of the heart) uses sound waves to image the carotid arteries. A gel is applied to the area of the neck to be imaged and a small handheld ultrasound probe is held against the neck to take the pictures. Participants return after 2 years for a second set of tests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2004

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2004

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 7, 2004

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

March 4, 2008

Status Verified

January 1, 2005

First QC Date

April 7, 2004

Last Update Submit

March 3, 2008

Conditions

Coronary Disease

Keywords

Intravascular UltrasoundMagnetic Resonance ImagingHyperlipidemiaCholesterolCoronary Artery Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart, Lung and Blood Institute (NHLBI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Corti R, Fuster V, Fayad ZA, Worthley SG, Helft G, Smith D, Weinberger J, Wentzel J, Mizsei G, Mercuri M, Badimon JJ. Lipid lowering by simvastatin induces regression of human atherosclerotic lesions: two years' follow-up by high-resolution noninvasive magnetic resonance imaging. Circulation. 2002 Dec 3;106(23):2884-7. doi: 10.1161/01.cir.0000041255.88750.f0.

    PMID: 12460866BACKGROUND

  • Fayad ZA. MR imaging for the noninvasive assessment of atherothrombotic plaques. Magn Reson Imaging Clin N Am. 2003 Feb;11(1):101-13. doi: 10.1016/s1064-9689(02)00023-5.

    PMID: 12797513BACKGROUND

  • Wasserman BA, Smith WI, Trout HH 3rd, Cannon RO 3rd, Balaban RS, Arai AE. Carotid artery atherosclerosis: in vivo morphologic characterization with gadolinium-enhanced double-oblique MR imaging initial results. Radiology. 2002 May;223(2):566-73. doi: 10.1148/radiol.2232010659.

    PMID: 11997569BACKGROUND

MeSH Terms

Conditions

Coronary DiseaseHyperlipidemiasCoronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesArteriosclerosisArterial Occlusive Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

April 7, 2004

First Posted

April 7, 2004

Study Start

April 1, 2004

Study Completion

January 1, 2005

Last Updated

March 4, 2008

Record last verified: 2005-01

Locations

US(1)