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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 and High Field (3T) MRI: A Technical Development Study of Cardiac and Body Imaging

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, Blood draws, Physical exams, X-rays

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Background: \- Imaging tests, such as magnetic resonance imaging (MRI), can provide information about heart and blood vessels."
  • "Objectives: \- To compare heart MRI techniques with other tests used to diagnose heart disease."
  • "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."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares new heart MRI methods with other tests for heart disease. It is for adults who have or may have heart disease, as well as healthy volunteers and people with certain other health conditions. The study does not provide treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18. The study summary says 18 or older, but the detailed rules say older than 18.
  • You may have heart or blood vessel disease, be at risk for it, or be a healthy volunteer.
  • You may also have a known or suspected disease of the chest or belly organs, or a disease affecting how your body uses energy, including body fat and muscles.
  • Be willing to join and able to give informed consent, meaning you understand the study and agree to take part.
  • Have stable health and be able to visit the Clinical Center.

Who can't join

  • You cannot safely have an MRI because of certain implants or metal in your body, such as a pacemaker, hearing implant, metal in an eye, or an implanted pump.
  • You are too ill to handle an MRI, need medicine to keep you calm or asleep for it, cannot fit in the scanner, fear tight spaces, or cannot lie on your back and stay still.
  • You are pregnant or breastfeeding.
  • You cannot have or schedule the required heart blood vessel tests within 2 months of the MRI blood vessel scan.
  • For MRI scans using gadolinium dye only: you have had an allergic reaction despite allergy medicines, or your kidney filtering test result (eGFR) is below 60.
  • For heart CT blood vessel scans only: you have a creatinine level above 1.4 (a kidney test), a history of the blood cancer multiple myeloma, metformin use within 24 hours before the dye, or a dye allergy despite allergy medicines.
  • For heart CT blood vessel scans only: you cannot take the needed heart-slowing medicine because of certain breathing problems, heart rhythm problems, worsening heart failure, a medicine allergy, or a top blood pressure number below 100.
  • For nitroglycerin use only: certain serious heart conditions, a top blood pressure number below 90, untreated low blood volume, high pressure inside the skull, glaucoma (an eye disease), severe anemia (too few healthy red blood cells), use of Viagra, Cialis, or Levitra, or an allergy to nitroglycerin.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

* 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/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

Study sites (1)

MD