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Protocol Number:
08-H-0185
- Title:
Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Normal Volunteers
- Number:
08-H-0185
- Summary:
This study will test new techniques to image the heart, blood vessels, and legs using magnetic resonance imaging (MRI). The techniques will be used to plan and guide treatments using minimally invasive methods.
Healthy normal volunteers 18 years of age and older may be eligible for this study.
For MRI, the subject lies flat on a table that can slide in and out of the scanner, a metal cyclinder. Special antennas, covered in pads, are placed against the subject's body. The scan time can vary from 20 minutes to 2 hours, with most scans lasting between 45 and 90 minutes. The subject may be asked to wear adhesive patches on the chest for monitoring the heart and a belt or finger pad for monitoring breathing. During the test, a contrast agent called gadolinium may be injected. This substance brightens the heart and arteries during the scan, providing a better picture of blood flow.
During the procedure, subjects may be asked to exercise their legs on a machine to evaluate the effects of motion and exercise on the MRI exam.
Large blood pressures cuffs may be placed on either or both thighs or calves to try to measure arterial flow to the legs. The cuffs are inflated to a pressure as high as at least 50 mmHg higher than thesubject's systolic blood pressure (up to 250 mmHg) for up to 10 minutes.
Subjects may be asked to return for repeated scans.
- Sponsoring Institute:
-
National Heart, Lung and Blood Institute (NHLBI)
- Recruitment Detail
- Type:
Participants currently recruited/enrolled
- Gender:
Male & Female
- Referral Letter Required:
No
- Population Exclusion(s):
Children
- Eligibility Criteria:
1. GENERAL INCLUSION CRITERIA:
- Normal adult volunteers, age is greater than 18 years of age, who consent to participate in writing
2. EXCLUSION CRITERIA: MRI risk
-Cardiac pacemaker or implantable defibrillator
-Cerebral aneurysm clip
-Implanted neural stimulator (e.g. TENS-Unit)
-Any type of ear or cochlear implant
-Intra-ocular foreign body (e.g. metal shavings)
-Any implanted device (e.g. insulin pump, drug infusion device)
-Metal shrapnel or bullet
-Morbid obesity
-Claustrophobia
3. EXCLUSION CRITERIA: Contrast media risk:
-Pregnant women (when uncertain, subjects will undergo urine or blood testing) or lactating women
-Known hemoglobinopathy
-Known kidney disease
-Exposure to gadolinium MRI contrast agents in the past 18 hours, if the study requires gadolinium MRI contrast agent.
-Diabetes
-Children are not included.
- Special Instructions:
Currently Not Provided
- Keywords:
-
Magnetic Resonance Imaging
-
Minimally Invasive Therapy
-
Heart Catheterization
-
Healthy Volunteers
-
Gadolinium Contrast
- Recruitment Keyword(s):
-
Healthy Volunteer
-
HV
- Condition(s):
-
Healthy
- Investigational Drug(s):
- None
- Investigational Device(s):
- None
- Intervention(s):
- None
- Supporting Site:
- National Heart, Lung, and Blood Institute
- Contact(s):
-
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793
Electronic Mail:prpl@mail.cc.nih.gov
- Citation(s):
-
Lederman RJ. Cardiovascular interventional magnetic resonance imaging. Circulation. 2005 Nov 8;112(19):3009-17. Review. No abstract available.
-
Haustein J, Laniado M, Niendorf HP, Louton T, Beck W, Planitzer J, Schšffel M, Reiser M, Kaiser W, Schšrner W, et al. Triple-dose versus standard-dose gadopentetate dimeglumine: a randomized study in 199 patients. Radiology. 1993 Mar;186(3):855-60.
-
Niendorf HP, Haustein J, Cornelius I, Alhassan A, Clauss W. Safety of gadolinium-DTPA: extended clinical experience. Magn Reson Med. 1991 Dec;22(2):222-8; discussion 229-32. Review.
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