AtherosclerosisNCT00382564
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
An observational study of Atherosclerosis and Hyperlipidemia, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
This study will determine the usefulness of magnetic resonance imaging (MRI) for examining the heart or blood vessels. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Hyperlipidemia, Hypertension
- How many people
- 216 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2006to 1 May 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with known or suspected atherosclerotic disease based on clinical findings or documented by angiography (conventional, CT or MRA), or Doppler ultrasound. Subjects at risk for atherosclerosis including: smoking, hyperlipidemia, low levels of high density lipoproteins (less than 50 mg/dl for women and less than 40 mg/dl for men), hypertension, family history (early onset atherosclerosis less than 55 year old in male and less than 65 year old in female who is first degree relative), and diabetes mellitus or metabolic syndrome.
- Subject must be willing to participate in the protocol.
- Subject age greater than 18 years old.
- Subject must be clinically stable and be able to come to the Clinical Center to participate in the study.
Who cannot join
- Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions:
- Implanted cardiac pacemaker or defibrillator
- Cochlear Implants
- Ocular foreign body (e.g. metal shavings)
- Embedded shrapnel fragments
- Central nervous system aneurysm clips
Show all 35Show fewer
- Implanted neural stimulator
- Medical infusion pumps
- Any implanted device that is incompatible with MRI.
- Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and dyspnea at rest.
- Subjects requiring sedation for MRI studies.
- Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.).
- Pregnant or lactating women.
- Subjects with severe back-pain or motion disorders who will be unable to tolerate supine positioning within the MRI scanner and hold still for the duration of the examination.
- Subjects who are unable to undergo a CTA within 1 month of the MRA part of this study, or are unable undergo or be scheduled for a cardiac catheterization within 1 month of the MRA.
- FOR GADOLINIUM BASED MRI STUDIES ONLY:
- History of severe allergic reaction to gadolinium contrast agents despite the use of premeditation with an anti-histaminic and cortisone.
- Creatinine value greater than 3.0 mg/dl
- FOR CARDIAC CT:
- Recent cardiac CT within a month. Both a coronary CTA and calcium score scan are required for this study. If any of these scans were performed at an outside facility and meet the necessary quality level, then that aspect of the cardiac CT scan (coronary CTA, calcium score scan or both) will not be performed at the NIH. Coronary CTA and/or calcium score CT obtained at the outside facility must be performed within one month of subject inclusion and acquired using a 16 slice scanner or higher and should be of good quality. The unformatted images of outside cardiac scans must be available to the primary investigator within one month of their acquisition for eligibility of inclusion in the study.
- FOR CORONARY CTA:
- Contraindication to the use of CT contrast agents:
- Creatinine value greater than 1.4 mg/dl
- History of multiple myeloma
- Use of metformin-containing products less than 24 hrs prior to contrast administration
- History of significant allergic reaction to CT contrast agents despite the use of premeditation with an anti-histaminic and cortisone.
- Subjects with contraindication precluding the use of beta blockers necessary to perform the coronary CTA. These include:
- Asthma
- Active bronchospasm
- Moderate or severe COPD
- Second or third degree AV block
- Decompensated cardiac failure
- Allergy to beta blockers
- Systolic blood pressure less than 100 mm Hg
- Pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Magnetic Resonance Angiography (MRA) in the Diagnosis of Atherosclerotic Disease Using High Field (3T) MRI Scanners: A Pilot Technical Development Study
This study will determine the usefulness of magnetic resonance imaging (MRI) for examining the heart or blood vessels. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that can slide in and out of the scanner (a metal cylinder), wearing earplugs to muffle loud noises that occur during the scanning process. MRI of the heart and blood vessels, called magnetic resonance angiography (MRA), is a developing diagnostic method that permits evaluation of arteries and veins without the use of x-rays or invasive catheterization required by conventional angiography.
People 18 years of age and older with known or suspected atherosclerotic disease may be eligible for this study.
Read more
Participants have blood tests and MRA scanning. The MRA takes about 1.5 to 2 hours. During part of the scan, a contrast agent may be injected into a vein to brighten the images of the heart and blood vessels. Subjects are monitored with an electrocardiogram and are asked to hold their breath for about 5 to 20 seconds intermittently during the procedure.
A CT scan may be done to confirm the MRA findings. CT uses x-rays to produce pictures of the heart and blood vessels. The subject lies on a bed during the scan and is given a contrast agent through a catheter inserted into a vein. Subjects are asked to hold their breath intermittently for about 5 to 20 seconds. A medicine called a beta blocker may be administered to slow the heart rate.
Read the detailed description
Magnetic Resonance Angiography (MRA) is a developing technique that permits the non-invasive evaluation of arterial and venous structures without the need for x-ray based catheter angiography. While dramatic progress has been made in the last few years, there are still substantial limitations in the accuracy of MRA in the evaluation of coronary artery. The primary aim of this study is to evaluate state-of-the-art techniques for coronary MRA in subjects with known or suspected coronary atherosclerosis. The secondary aim of this protocol is to generate natural history data for future hypothesis-driven clinical trials using MRA techniques developed in this current protocol. The long-term objective of this pilot study and research initiative is to improve coronary MRA to the point that it can reliably replace diagnostic x-ray catheter angiography in the evaluation of subjects with atherosclerotic disease.
- Conditions
- Atherosclerosis, Hyperlipidemia, Hypertension, Diabetes Mellitus
- Keywords
- Imaging, Arteriosclerosis, Hardening of the arteries, MRA, Narrowing of Vessels, Noninvasive Plaque Imaging, Atherosclerotic Disease, Plaque, Arteries, Diabetes, Hypertension
- Medical subject headings
- Atherosclerosis, Hyperlipidemias, Hypertension, Diabetes Mellitus, Arteriosclerosis, Plaque, Amyloid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2006 (estimated)
- Study start25 Sep 2006
- Study completion1 May 2012
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 AtherosclerosisStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)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
- 216 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Ahmed M Gharib, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00382564
- Sponsor's protocol ID
- 060249
- Other IDs
- 06-DK-0249
- Status last verified
- 1 May 2012
- First submitted
- 28 Sep 2006
- Last updated
- 6 Oct 2017
- Results posted
- No
Publications
Kim WY, Danias PG, Stuber M, Flamm SD, Plein S, Nagel E, Langerak SE, Weber OM, Pedersen EM, Schmidt M, Botnar RM, Manning WJ. Coronary magnetic resonance angiography for the detection of coronary stenoses. N Engl J Med. 2001 Dec 27;345(26):1863-9. doi: 10.1056/NEJMoa010866.
PubMed 11756576Lopez AD, Murray CC. The global burden of disease, 1990-2020. Nat Med. 1998 Nov;4(11):1241-3. doi: 10.1038/3218. No abstract available.
PubMed 9809543Hoffmann MH, Shi H, Schmitz BL, Schmid FT, Lieberknecht M, Schulze R, Ludwig B, Kroschel U, Jahnke N, Haerer W, Brambs HJ, Aschoff AJ. Noninvasive coronary angiography with multislice computed tomography. JAMA. 2005 May 25;293(20):2471-8. doi: 10.1001/jama.293.20.2471.
PubMed 15914747
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Angiography (MRA) in the Diagnosis of Atherosclerotic Disease Using High Field (3T) MRI Scanners: A Pilot Technical Development Study
- ClinicalTrials.gov ID
- NCT00382564
- Acronym / sponsor ID
- 060249
- Conditions
- Atherosclerosis, Hyperlipidemia, Hypertension, Diabetes Mellitus
- Keywords
- Imaging, Arteriosclerosis, Hardening of the arteries, MRA, Narrowing of Vessels, Noninvasive Plaque Imaging, Atherosclerotic Disease, Plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 25 Sep 2006
- Study completion
- 1 May 2012
- First posted
- 29 Sep 2006 (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 determine the usefulness of magnetic resonance imaging (MRI) for examining the heart or blood vessels. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. The subject lies on a table that can slide in and out of the scanner (a metal cylinder), wearing earplugs to muffle loud noises that occur during the scanning process. MRI of the heart and blood vessels, called magnetic resonance angiography (MRA), is a developing diagnostic method that permits evaluation of arteries and veins without the use of x-rays or invasive catheterization required by conventional angiography.
People 18 years of age and older with known or suspected atherosclerotic disease may be eligible for this study.
Participants have blood tests and MRA scanning. The MRA takes about 1.5 to 2 hours. During part of the scan, a contrast agent may be injected into a vein to brighten the images of the heart and blood vessels. Subjects are monitored with an electrocardiogram and are asked to hold their breath for about 5 to 20 seconds intermittently during the procedure.
A CT scan may be done to confirm the MRA findings. CT uses x-rays to produce pictures of the heart and blood vessels. The subject lies on a bed during the scan and is given a contrast agent through a catheter inserted into a vein. Subjects are asked to hold their breath intermittently for about 5 to 20 seconds. A medicine called a beta blocker may be administered to slow the heart rate.
Detailed description
Magnetic Resonance Angiography (MRA) is a developing technique that permits the non-invasive evaluation of arterial and venous structures without the need for x-ray based catheter angiography. While dramatic progress has been made in the last few years, there are still substantial limitations in the accuracy of MRA in the evaluation of coronary artery. The primary aim of this study is to evaluate state-of-the-art techniques for coronary MRA in subjects with known or suspected coronary atherosclerosis. The secondary aim of this protocol is to generate natural history data for future hypothesis-driven clinical trials using MRA techniques developed in this current protocol. The long-term objective of this pilot study and research initiative is to improve coronary MRA to the point that it can reliably replace diagnostic x-ray catheter angiography in the evaluation of subjects with atherosclerotic disease.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (35 listed)
- Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions:
- Unsatisfactory performance status as judged by the referring physician such that the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and dyspnea at rest.
- Subjects requiring sedation for MRI studies.
- Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.).
- Pregnant or lactating women.
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 6 Oct 2017.
- Background: PubMed 11756576Kim WY, Danias PG, Stuber M, Flamm SD, Plein S, Nagel E, Langerak SE, Weber OM, Pedersen EM, Schmidt M, Botnar RM, Manning WJ. Coronary magnetic resonance angiography for the detection of coronary stenoses. N Engl J Med. 2001 Dec 27;345(26):1863-9. doi: 10.1056/NEJMoa010866.
- Background: PubMed 9809543Lopez AD, Murray CC. The global burden of disease, 1990-2020. Nat Med. 1998 Nov;4(11):1241-3. doi: 10.1038/3218. No abstract available.
- Background: PubMed 15914747Hoffmann MH, Shi H, Schmitz BL, Schmid FT, Lieberknecht M, Schulze R, Ludwig B, Kroschel U, Jahnke N, Haerer W, Brambs HJ, Aschoff AJ. Noninvasive coronary angiography with multislice computed tomography. JAMA. 2005 May 25;293(20):2471-8. doi: 10.1001/jama.293.20.2471.
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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.
Ahmed M Gharib, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Atherosclerosis and Hyperlipidemia, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 4 inclusion and 35 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 6 Oct 2017. 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 NCT00382564, 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 6 Oct 2017.