Status:
COMPLETED
Gadofosveset Trisodium for Heart Imaging Studies
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Obstructive Coronary Artery Disease
Coronary Arteriosclerosis
Eligibility:
All Genders
18-45 years
Brief Summary
Background: \- Magnetic resonance imaging (MRI) is type of imaging study that uses magnetic fields and radio waves to take pictures of the body. To help the images show up more clearly, a contrast ag...
Detailed Description
The purpose of this study is to determine if the diagnostic quality of contrast-enhanced coronary magnetic resonance angiography (MRA) is improved by using a higher versus a lower dose of a gadolinium...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A. Able to understand and sign informed consent.
- B. Able to complete an MRI scan.
- C. Age 18-45 years old.
- D. eGFR greater than or equal to 60mL/min/1.73m(2) within 1 week prior to gadolinium injection.
- E. NIH employees may be involved and NIH requirements will be followed as laid out in NIH Policy Manual 2300-630-3 - Leave Policy for NIH Employees Participating in NIH Medical Research Studies.
- F. Willing to travel to the NIH for scheduled follow-up visits and scans as well as potential repeat scans in the event of sub-optimal scanning.
- EXCLUSION CRITERIA:
- Individuals will be excluded from the study if they have:
- A. Contra-indications to undergoing a MRA
- Please review Radiology MRI section MRI safety questionnaire.
- B. MRI with contrast within the last 6 months (self-reported) outside of our protocol.
- C. Contra indications to receiving gadolinium-based contrast agent (specified here and on MRI safety questionnaire):
- Allergy to gadolinium-based contrast
- Labs:
- i. Kidney and liver function above the upper limits of normal
- ii. eGFR \< 60ml/min/1.73m(2)
- iii. Pregnancy test: positive
- c. Acute renal failure, renal transplantation, curent dialysis treatment or hepatorenal syndrome
- d. History of liver transplantation or severe liver disease
- e. Severe Asthma
- f. Hemoglobinopathies
- g. History of multiple myeloma
- h. History of significant allergic reaction to gadolinium-based contrast agents
- i. Evaluated to be at increased risk for Nephrogenic Systemic Fibrosis (NSF).
- D. Current written (or self-reported) record of:
- atrial fibrillation
- cardiac surgery
- cancer treatment
- other comorbid conditions that otherwise indicates the participant has renal function that may deteriorate between study procedures due to the participant s underlying medical condition or that would not allow the study subject to complete the protocol.
- E. Current written (or self-reported) record of active:
- Clinically diagnosed angina, heart failure, and/or clinically significant electrical conduction abnormality in the heart.
- Pregnancy or lactation
- Mental, neurologic or social condition preventing understanding of the rationale, procedures, risks and potential benefits associated with the trial
- Paralyzed hemidiaphragm
- Over 400 lbs and/or a body circumference that prevents adequate MRI gantry insertion.
- Unable to lay flat in the scanner
- Claustrophobia otherwise requiring anesthesia or sedation to undergo MRI.
- Participant is not able to undergo intravenous line placement and/or refuse gadolinium contrast.
- F. Any other conditions that precludes safety for MRI per the researcher s evaluation.
Exclusion
Key Trial Info
Start Date :
March 8 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 13 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01853592
Start Date
March 8 2013
End Date
December 13 2016
Last Update
September 10 2018
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892