Phase
Condition
Obesity
Healthy Volunteers
Diabetic Neuropathy
Treatment
MR Imaging Techniques - 3
MR Imaging Techniques - 4
MR Imaging Techniques - 2
Clinical Study ID
Ages 18-100 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
- INCLUSION:
Subjects with or without history of cardiovascular diseases and with variousdegrees of cardiovascular risk factor. Subjects with known or suspectedatherosclerotic disease based on clinical findings or documented by angiography (conventional, CTA or MRA), or Doppler ultrasound. And, healthy volunteers andsubjects with known or suspected diseases affecting the thoracic organs,abdominal organs, and other organs affected by metabolic diseases such as bodyfat and muscles. Subjects at risk for atherosclerosis including: smoking,obesity, hyperlipidemia, low levels of high density lipoproteins (<50 mg/dl forwomen and <40 mg/dl for men), hypertension, family history (early onsetatherosclerosis <55 year old in male and < 65 year old in female who is firstdegree relative), and diabetes mellitus or metabolic syndrome.
Subject must be willing to participate in the protocol.
Subject age greater than 18 years old.
Subject must be able to provide informed consent.
Subject must be clinically stable and be able to come to the Clinical Center toparticipate in the study.
Exclusion
EXCLUSION CRITERIA:
Subjects with contraindication to MRI scanning. These contraindications include butare not limited to the following devices or conditions:
Implanted cardiac pacemaker or defibrillator
Cochlear Implants
Ocular foreign body (e.g. metal shavings)
Embedded shrapnel fragments
Central nervous system aneurysm clips
Implanted neural stimulator
Medical infusion pumps
Any implanted device that is incompatible with MRI.
Unsatisfactory performance status as judged by the referring physician such that thesubject could not tolerate an MRI scan. Examples of medical conditions that wouldnot be accepted would include unstable angina and dyspnea at rest.
Subjects requiring sedation for MRI studies.
Subjects with a condition precluding entry into the scanner (e.g. morbid obesity,claustrophobia, etc.).
Pregnant or lactating women.
Subjects with severe back-pain or motion disorders who will be unable to toleratesupine positioning within the MRI scanner and hold still for the duration of theexamination.
Subjects who are unable to undergo a CTA within 2 months of the MRA part of thisstudy, 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:
History of allergic reaction to gadolinium contrast agents despite the use ofpremeditation with an anti-histaminic and cortisone.
eGFR < 60 ml/min/1.73m^2
EXCLUSION CRITERIA - FOR CORONARY CTA:
Contraindication to the use of CTA contrast agents:
Creatinine value > 1.4 mg/dl
History of multiple myeloma
Use of metformin-containing products less than 24 hrs prior to contrastadministration
History of allergic reaction to CTA contrast agents despite the use of pre-medication with an anti-histaminic and cortisone.
Subjects with contraindication precluding the use of beta blockers necessary toperform the coronary CTA. These include:
Asthma
Active bronchospasm
Moderate or severe COPD
2nd or 3rd degree AV block
Decompensated cardiac failure
Allergy to beta blockers
Systolic blood pressure < 100 mm Hg
Pregnancy or nursing
EXCLUSION CRITERIA - FOR NITROGLYCERIN USE:
Subjects reporting a history of the following conditions will be excluded:
Severe aortic stenosis
Hypertrophic cardiomyopathy
Inferior myocardial infarction with right ventricular involvement
Cardiac tamponade
Constrictive pericarditis
Severe hypotension (systolic BP <90 mmHg)
Uncorrected hypovolemia
Raised intracranial pressure
Glaucoma
Severe anemia
Concomitant use of phosphodiesterase-5 inhibitors (sildenafil-Viagra,tadalifil-Cialis, verdenafil-Levitra)
History of hypersensitivity to nitroglycerin
Study Design
Study Description
Connect with a study center
National Institutes of Health Clinical Center
Bethesda, Maryland 20892
United StatesActive - Recruiting
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