New Heart Imaging Techniques to Evaluate Possible Heart Disease

Last updated: May 10, 2025
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Healthy Volunteers

Diabetic Neuropathy

Treatment

MR Imaging Techniques - 3

MR Imaging Techniques - 4

MR Imaging Techniques - 2

Clinical Study ID

NCT01399385
110168
11-DK-0168
  • Ages 18-100
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

  • INCLUSION:
  1. Subjects with or without history of cardiovascular diseases and with variousdegrees of cardiovascular risk factor. Subjects with known or suspectedatherosclerotic disease based on clinical findings or documented by angiography (conventional, CTA or MRA), or Doppler ultrasound. And, healthy volunteers andsubjects with known or suspected diseases affecting the thoracic organs,abdominal organs, and other organs affected by metabolic diseases such as bodyfat and muscles. Subjects at risk for atherosclerosis including: smoking,obesity, hyperlipidemia, low levels of high density lipoproteins (<50 mg/dl forwomen and <40 mg/dl for men), hypertension, family history (early onsetatherosclerosis <55 year old in male and < 65 year old in female who is firstdegree relative), and diabetes mellitus or metabolic syndrome.

  2. Subject must be willing to participate in the protocol.

  3. Subject age greater than 18 years old.

  4. Subject must be able to provide informed consent.

  5. Subject must be clinically stable and be able to come to the Clinical Center toparticipate in the study.

Exclusion

EXCLUSION CRITERIA:

  1. Subjects with contraindication to MRI scanning. These contraindications include butare not limited to the following devices or conditions:

  2. Implanted cardiac pacemaker or defibrillator

  3. Cochlear Implants

  4. Ocular foreign body (e.g. metal shavings)

  5. Embedded shrapnel fragments

  6. Central nervous system aneurysm clips

  7. Implanted neural stimulator

  8. Medical infusion pumps

  9. Any implanted device that is incompatible with MRI.

  10. Unsatisfactory performance status as judged by the referring physician such that thesubject could not tolerate an MRI scan. Examples of medical conditions that wouldnot be accepted would include unstable angina and dyspnea at rest.

  11. Subjects requiring sedation for MRI studies.

  12. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity,claustrophobia, etc.).

  13. Pregnant or lactating women.

  14. Subjects with severe back-pain or motion disorders who will be unable to toleratesupine positioning within the MRI scanner and hold still for the duration of theexamination.

  15. Subjects who are unable to undergo a CTA within 2 months of the MRA part of thisstudy, or are unable to undergo or be scheduled for a cardiac catheterization within 2 months of the MRA.

EXCLUSION CRITERIA - FOR GADOLINIUM BASED MRI STUDIES ONLY:

  1. History of allergic reaction to gadolinium contrast agents despite the use ofpremeditation with an anti-histaminic and cortisone.

  2. eGFR < 60 ml/min/1.73m^2

EXCLUSION CRITERIA - FOR CORONARY CTA:

  1. Contraindication to the use of CTA contrast agents:

  2. Creatinine value > 1.4 mg/dl

  3. History of multiple myeloma

  4. Use of metformin-containing products less than 24 hrs prior to contrastadministration

  5. History of allergic reaction to CTA contrast agents despite the use of pre-medication with an anti-histaminic and cortisone.

  6. Subjects with contraindication precluding the use of beta blockers necessary toperform the coronary CTA. These include:

  7. Asthma

  8. Active bronchospasm

  9. Moderate or severe COPD

  10. 2nd or 3rd degree AV block

  11. Decompensated cardiac failure

  12. Allergy to beta blockers

  13. Systolic blood pressure < 100 mm Hg

  14. Pregnancy or nursing

EXCLUSION CRITERIA - FOR NITROGLYCERIN USE:

Subjects reporting a history of the following conditions will be excluded:

  1. Severe aortic stenosis

  2. Hypertrophic cardiomyopathy

  3. Inferior myocardial infarction with right ventricular involvement

  4. Cardiac tamponade

  5. Constrictive pericarditis

  6. Severe hypotension (systolic BP <90 mmHg)

  7. Uncorrected hypovolemia

  8. Raised intracranial pressure

  9. Glaucoma

  10. Severe anemia

  11. Concomitant use of phosphodiesterase-5 inhibitors (sildenafil-Viagra,tadalifil-Cialis, verdenafil-Levitra)

  12. History of hypersensitivity to nitroglycerin

Study Design

Total Participants: 4000
Treatment Group(s): 4
Primary Treatment: MR Imaging Techniques - 3
Phase:
Study Start date:
July 06, 2011
Estimated Completion Date:
November 05, 2030

Study Description

Specialized imaging techniques now available allow a unique opportunity to characterize the micro-environment of the human body. Magnetic Resonance (MR) vascular wall imaging and angiography (MRA) are developing techniques that permit non-invasive evaluation of arterial and venous structures without the need for x-ray based catheter angiography. In addition, vessel wall imaging provides unprecedented non-invasive tools to assess vascular endothelial function. While dramatic progress has been made to cardiovascular MR imaging in the last few years, there are still substantial limitations in the resolution, accuracy, and reproducibility of MRA and wall imaging in the comprehensive structural and functional evaluation of coronary artery. The first aim of this study is to develop and optimize clinical imaging protocols and techniques for fast high-resolution coronary MRA and wall imaging for the assessment of coronary and other main arteries structural, distensibility, and endothelial functional parameters. Technique optimization and performance evaluation will be accomplished in normal subjects without known or suspected coronary atherosclerosis. The second aim of this protocol is to evaluate early MR imagery signs of arterial structural, distensibility, and endothelial functional disorders associated with atherosclerosis in a cohort of patients with known or suspected coronary atherosclerosis. Results from accelerated high-resolution MRA will be correlated with corresponding Computerized Tomography Coronary Angiogram (CTA) results. The third aim of this protocol is to develop, implement, and optimize new non-invasive methods for characterization of the micro-environment in the thoracic and abdominal area utilizing specialized techniques such as MR Spectroscopy, MR Elastography, and blood oxygenation level dependent (BOLD) imaging. The long-term objective of this study and research initiative is to optimize coronary MRA, wall, and body imaging techniques to the point that it can reliably be used for routine prevention and assessment of early atherosclerosis and other diseases.

Connect with a study center

  • National Institutes of Health Clinical Center

    Bethesda, Maryland 20892
    United States

    Active - Recruiting

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