NCT01399385Recruiting
New Heart Imaging Techniques to Evaluate Possible Heart Disease
Magnetic Resonance of Body, Arterial Wall, and Angiography Imaging for Non- Invasive Assessment of Arterial Distensibility, Endothelial Dysfunction and Atherosclerotic Disease Using 1.5T and High Field (3T) MRI: A Technical Development Study of Cardiac and Body Imaging
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
Background: \- Imaging tests, such as magnetic resonance imaging (MRI), can provide information about heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing and vessel wall thickness. This information may help diagnose and treat heart disease and other conditions that lead to heart attacks. Better MRI methods are needed to improve heart disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new techniques to improve the quality of heart MRI, compared with more complex studies like catheterization or angiography. Objectives: \- To compare heart MRI techniques with other tests used to diagnose heart disease. Eligibility: \- People at least 18 years of age who either have or may have heart disease, or are healthy volunteers. Design: * Participants will be screened with a physical exam, medical history, and blood tests. * They will have an angiography to study the inside of blood vessels. This test is an x-ray study of the blood vessels. It will be done either separately or as part of a set of tests to diagnose possible heart disease. * Participants will have at least one and up to five MRI scans. The scans will involve different methods of studying the heart and blood vessels. Participants may also have a computed tomography scan to confirm the findings of an MRI scan. * No treatment will be provided as part of this protocol.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 4000 (estimated)
- First submitted
- 20 Jul 2011
- Start date
- 6 Jul 2011
- Primary completion date
- 6 Nov 2028
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Diseases
- Obesity
- NCT number
- NCT01399385
What you commit to
- Study type: Interventional
- Planned participants: 4000
- From 6 Jul 2011 to the primary completion date, 6 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant use of phosphodiesterase-5 inhibitors (sildenafil-Viagra, tadalifil-Cialis, verdenafil-Levitra)
Other illness
- 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
- 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 with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.).
- 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 2 months of the MRA part of this study, or are unable to undergo or be scheduled for a cardiac catheterization within 2 months of the MRA.
- History of allergic reaction to gadolinium 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
- 2nd or 3rd degree AV block
- Decompensated cardiac failure
- Allergy to beta blockers
- Systolic blood pressure \< 100 mm Hg
- Pregnancy or nursing
- Subjects reporting a history of the following conditions will be excluded:
- Inferior myocardial infarction with right ventricular involvement
- Cardiac tamponade
- History of hypersensitivity to nitroglycerin
Lab values
- eGFR \< 60 ml/min/1.73m\^2
- Contraindication to the use of CTA contrast agents:
- Creatinine value \> 1.4 mg/dl
- History of multiple myeloma
- Use of metformin-containing products less than 24 hrs prior to contrast administration
- History of allergic reaction to CTA contrast agents despite the use of pre- medication with an anti-histaminic and cortisone.
Other
- Subjects requiring sedation for MRI studies.
- Pregnant or lactating women.
- Severe aortic stenosis
- Hypertrophic cardiomyopathy
- Constrictive pericarditis
- Severe hypotension (systolic BP \<90 mmHg)
- Uncorrected hypovolemia
- Raised intracranial pressure
- Glaucoma
- Severe anemia
Criteria the registry did not label
- INCLUSION CRITERIA:
- Subjects with or without history of cardiovascular diseases and with various degrees of cardiovascular risk factor. Subjects with known or suspected atherosclerotic disease based on clinical findings or documented by angiography (conventional, CTA or MRA), or Doppler ultrasound. And, healthy volunteers and subjects with known or suspected diseases affecting the thoracic organs, abdominal organs, and other organs affected by metabolic diseases such as body fat and muscles. Subjects at risk for atherosclerosis including: smoking, obesity, hyperlipidemia, low levels of high density lipoproteins (\<50 mg/dl for women and \<40 mg/dl for men), hypertension, family history (early onset atherosclerosis \<55 year old in male and \< 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 able to provide informed consent.
- Subject must be clinically stable and be able to come to the Clinical Center to participate in the study.
Age in the registry: 18 years to 100 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institutes of Health Clinical Center Coordinator of this site? Confirm its status | Bethesda | United States | Recruiting |
Related publications
- Personalized Statin Therapy and Coronary Atherosclerotic Plaque Burden in Asymptomatic Low/Intermediate-Risk Individuals.Cardiorenal Med · 2018 · PMID 29617001
This page is information, not medical advice. Discuss any trial with your doctor.