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Official title New Heart Imaging Techniques to Evaluate Possible Heart Disease
ClinicalTrials.gov ID: NCT01399385
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100. Healthy volunteers may be eligible.
You may be able to join if
- INCLUSION:
- people with or without history of cardiovascular diseases and with various degrees of cardiovascular risk factor. people with known or suspected...
- Subject must be willing to participate in the protocol.
- Subject age greater than 18 years old.
- Subject must be able to provide informed consent.
You likely can't join if
- people with contraindication to MRI scanning. These contraindications include but are 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
See the full eligibility criteria
- INCLUSION:
- people with or without history of cardiovascular diseases and with various degrees of cardiovascular risk factor. people with known or suspected atherosclerotic disease based on clinical findings or documented by...
- 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 to participate in the study.
- people with contraindication to MRI scanning. These contraindications include but are 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 the subject could not tolerate an MRI scan. Examples of medical conditions that would not be accepted would include unstable angina and...
- people requiring sedation for MRI studies.
- people with a condition precluding entry into the scanner (e.g. morbid obesity, claustrophobia, etc.).
- Pregnant or lactating women.
- people 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.
- people 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...
- History of allergic reaction to gadolinium contrast agents despite the use of premeditation 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 contrast administration
- History of allergic reaction to CTA contrast agents despite the use of pre- medication with an anti-histaminic and cortisone.
- people with contraindication precluding the use of beta blockers necessary to perform 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: people 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
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.