New Heart Imaging Techniques to Evaluate Possible Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01399385
First received: July 20, 2011
Last updated: August 29, 2014
Last verified: August 2014

July 20, 2011
August 29, 2014
June 2011
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Coronary segmental involvement scores [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT01399385 on ClinicalTrials.gov Archive Site
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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 High Field (3T) MRI: A Technical Development Study of Cardiac and Body

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.

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.

Observational
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  • Healthy
  • Obesity
  • Diabetes
  • Arteriosclerosis
  • Healthy Volunteers
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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  • INCLUSION CRITERIA:

    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 over dl for women and < 40 mg over 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.

EXCLUSION CRITERIA:

  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 1 month of the MRA part of this study, or are unable to undergo or be scheduled for a cardiac catheterization within 1 month of the MRA.
Both
18 Years and older
Yes
Contact: Jatin R Matta, P.A.-C (301) 435-2290 mattaj@mail.nih.gov
Contact: Ahmed M Gharib, M.D. (301) 451-8982 agharib@mail.nih.gov
United States
 
NCT01399385
110168, 11-DK-0168
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Principal Investigator: Ahmed M Gharib, M.D. National Institutes of Health Clinical Center (CC)
National Institutes of Health Clinical Center (CC)
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP