RECRUITING

New Heart Imaging Techniques to Evaluate Possible Heart Disease

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Conditions

HealthyObesityDiabetesHealthy VolunteersAtherosclerosisDistensibility ImagingArteriosclerosis, Narrowing of VesselsEndothelial DysfunctionHardening of the arteriesNon-Invasive Plaque ImagingCardiovascular DiseaseHeart DiseaseArteriosclerosisHealthy VolunteerHV

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2011-07-06
Study Completion:2030-11-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01399385

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Subjects with contraindication to MRI scanning. These contraindications include but are not limited to the following devices or conditions:
  2. 1. Implanted cardiac pacemaker or defibrillator
  3. 2. Cochlear Implants
  4. 3. Ocular foreign body (e.g. metal shavings)
  5. 4. Embedded shrapnel fragments
  6. 5. Central nervous system aneurysm clips
  7. 6. Implanted neural stimulator
  8. 7. Medical infusion pumps
  9. 8. Any implanted device that is incompatible with MRI.
  10. 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.
  11. 3. Subjects requiring sedation for MRI studies.
  12. 4. Subjects with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.).
  13. 5. Pregnant or lactating women.
  14. 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.
  15. 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.
  16. 1. History of allergic reaction to gadolinium contrast agents despite the use of premeditation with an anti-histaminic and cortisone.
  17. 2. eGFR \< 60 ml/min/1.73m\^2
  18. 1. Contraindication to the use of CTA contrast agents:
  19. 1. Creatinine value \> 1.4 mg/dl
  20. 2. History of multiple myeloma
  21. 3. Use of metformin-containing products less than 24 hrs prior to contrast administration
  22. 4. History of allergic reaction to CTA contrast agents despite the use of pre- medication with an anti-histaminic and cortisone.
  23. 2. Subjects with contraindication precluding the use of beta blockers necessary to perform the coronary CTA. These include:
  24. 1. Asthma
  25. 2. Active bronchospasm
  26. 3. Moderate or severe COPD
  27. 4. 2nd or 3rd degree AV block
  28. 5. Decompensated cardiac failure
  29. 6. Allergy to beta blockers
  30. 7. Systolic blood pressure \< 100 mm Hg
  31. 8. Pregnancy or nursing
  32. 1. Severe aortic stenosis
  33. 2. Hypertrophic cardiomyopathy
  34. 3. Inferior myocardial infarction with right ventricular involvement
  35. 4. Cardiac tamponade
  36. 5. Constrictive pericarditis
  37. 6. Severe hypotension (systolic BP \<90 mmHg)
  38. 7. Uncorrected hypovolemia
  39. 8. Raised intracranial pressure
  40. 9. Glaucoma
  41. 10. Severe anemia
  42. 11. Concomitant use of phosphodiesterase-5 inhibitors (sildenafil-Viagra, tadalifil-Cialis, verdenafil-Levitra)
  43. 12. History of hypersensitivity to nitroglycerin

Contacts and Locations

Study Contact

Jatin R Matta, P.A.-C
CONTACT
(301) 443-8373
mattaj@mail.nih.gov
Ahmed M Gharib, M.D.
CONTACT
(301) 402-5744
agharib@mail.nih.gov

Principal Investigator

Ahmed M Gharib, M.D.
PRINCIPAL_INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Ahmed M Gharib, M.D., PRINCIPAL_INVESTIGATOR, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2011-07-06
Study Completion Date2030-11-05

Study Record Updates

Study Start Date2011-07-06
Study Completion Date2030-11-05

Terms related to this study

Keywords Provided by Researchers

  • Distensibility Imaging
  • Arteriosclerosis, Narrowing of Vessels
  • Endothelial Dysfunction
  • Hardening of the arteries
  • Non-Invasive Plaque Imaging
  • Cardiovascular Disease
  • Heart Disease
  • Arteriosclerosis
  • Healthy Volunteer
  • HV

Additional Relevant MeSH Terms

  • Healthy
  • Obesity
  • Diabetes
  • Healthy Volunteers
  • Atherosclerosis