Clinical trial NCT01399385: New Heart Imaging Techniques to Evaluate Possible Heart Disease
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 and High Field (3T) MRI: A Technical Development Study of Cardiac and Body Imaging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Obesity
Diabetes
Healthy Volunteers
Atherosclerosis
Keywords: Distensibility Imaging
Arteriosclerosis, Narrowing of Vessels
Endothelial Dysfunction
Hardening of the arteries
Non-Invasive Plaque Imaging
Cardiovascular Disease
Heart Disease
Arteriosclerosis
Healthy Volunteer
HV
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2011-07-21
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: * INCLUSION:

  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.

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 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.

EXCLUSION CRITERIA - FOR GADOLINIUM BASED MRI STUDIES ONLY:

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

EXCLUSION CRITERIA - FOR CORONARY CTA:

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 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

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

Primary outcomes:
measure: 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@...
timeFrame: within one month
measure: 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
timeFrame: within one month
measure: To develop, implement, and optimize new non-invasive methods for characterization of the micro-environment in the thoracic and abdominal area utilizing specialized techniques
timeFrame: within one month
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Ahmed M Gharib, M.D.
role: PRINCIPAL_INVESTIGATOR
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