Coronary DiseaseNCT00080587
Atherosclerosis in the Coronary and Carotid Arteries
An observational study of Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Disease
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Jan 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
Official title: Atherosclerosis in the Coronary and Carotid Arteries: Correlations Between Coronary IVUS, Carotid Ultrasound, and Carotid MRI
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Coronary Disease
- Keywords
- Intravascular Ultrasound, Magnetic Resonance Imaging, Hyperlipidemia, Cholesterol, Coronary Artery Disease
- Medical subject headings
- Coronary Disease, Hyperlipidemias, Coronary Artery Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2004 (estimated)
- Study startApr 2004
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 125 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080587
- Sponsor's protocol ID
- 040154
- Other IDs
- 04-H-0154
- Status last verified
- Jan 2005
- First submitted
- 7 Apr 2004
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 12460866Fayad 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.
PubMed 12797513Wasserman 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.
PubMed 11997569
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atherosclerosis in the Coronary and Carotid Arteries: Correlations Between Coronary IVUS, Carotid Ultrasound, and Carotid MRI
- ClinicalTrials.gov ID
- NCT00080587
- Acronym / sponsor ID
- 040154
- Conditions
- Coronary Disease
- Keywords
- Intravascular Ultrasound, Magnetic Resonance Imaging, Hyperlipidemia, Cholesterol, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Apr 2004
- Study completion
- Jan 2005
- First posted
- 7 Apr 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- Pacemaker
- Defibrillator
- Brain aneurysm clips
- Implanted active medical devices (neural stimulators, cochlear implants, insulin pumps, etc.)
- Severe claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 12460866Corti 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.
- Background: PubMed 12797513Fayad 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.
- Background: PubMed 11997569Wasserman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00080587, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.