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New Heart Imaging Techniques to Evaluate Possible Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01399385
Recruitment Status : Recruiting
First Posted : July 21, 2011
Last Update Posted : April 8, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Brief Summary:


- 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.


- To compare heart MRI techniques with other tests used to diagnose heart disease.


- People at least 18 years of age who either have or may have heart disease, or are healthy volunteers.


  • 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.

Condition or disease
Healthy Obesity Diabetes Arteriosclerosis Healthy Volunteers

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 99999999 participants
Time Perspective: Other
Official Title: Magnetic Resonance of Body, Arterial Wall and Angiography Imaging for Non-Invasive Assessment of Arterial Distensibility, Endothelial Dysfunction and Atherosclerotic Disease Using 1.5T High Field (3T) MRI: A Technical Development Study of Cardiac and Body
Actual Study Start Date : July 6, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases

Primary Outcome Measures :
  1. Coronary segmental involvement scores

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

    1. 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.
    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 to participate in the study.


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

    1. Implanted cardiac pacemaker or defibrillator
    2. Cochlear Implants
    3. Ocular foreign body (e.g. metal shavings)
    4. Embedded shrapnel fragments
    5. Central nervous system aneurysm clips
    6. Implanted neural stimulator
    7. Medical infusion pumps
    8. Any implanted device that is incompatible with MRI.
  2. 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.
  3. Subjects requiring sedation for MRI studies.
  4. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.).
  5. Pregnant or lactating women.
  6. 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.
  7. 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.


  1. History of allergic reaction to gadolinium contrast agents despite the use of premeditation with an anti-histaminic and cortisone.
  2. eGFR < 60 ml/min/1.73m^2


  1. Contraindication to the use of CTA contrast agents:

    1. Creatinine value > 1.4 mg/dl
    2. History of multiple myeloma
    3. Use of metformin-containing products less than 24 hrs prior to contrast administration
    4. History of allergic reaction to CTA contrast agents despite the use of pre- medication with an anti-histaminic and cortisone.
  2. Subjects with contraindication precluding the use of beta blockers (Appendix C) necessary to perform the coronary CTA. These include:

    1. Asthma
    2. Active bronchospasm
    3. Moderate or severe COPD
    4. 2nd or 3rd degree AV block
    5. Decompensated cardiac failure
    6. Allergy to beta blockers
    7. Systolic blood pressure < 100 mm Hg
    8. Pregnancy or nursing


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01399385

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Contact: Jatin R Matta, P.A.-C (301) 435-2290
Contact: Ahmed M Gharib, M.D. (301) 451-8982

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Ahmed M Gharib, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier: NCT01399385     History of Changes
Other Study ID Numbers: 110168
First Posted: July 21, 2011    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 1, 2019
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Arteriosclerosis, Narrowing of Vessels
Endothelial Dysfunction
Hardening of the arteries
Noninvasive Plaque Imaging
Cardiovascular Disease
Heart Disease
Healthy Volunteer
Additional relevant MeSH terms:
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Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases