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Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Normal Volunteers
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), July 2008
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00720460
  Purpose

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.


Condition Phase
Healthy
Phase 0

MedlinePlus related topics: MRI Scans Nuclear Scans
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Normal Volunteers

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 250
Study Start Date: July 2008
Detailed Description:

We will evaluate new developments in fast magnetic resonance imaging (MRI) of the heart and blood vessels on normal volunteers. These studies will be conducted in the NIH MRI systems located at the NIH Clinical Center in Bethesda, Maryland. These procedures may involve the intravenous administration of commercially available MR contrast media, supine exercise or the inflation of blood pressure cuffs on the lower extremities during the MRI imaging. The results will be used to evaluate the performance of various research pulse sequences, gradient coils, and radiofrequency receiver coils on human subjects and will provide essential ground work for specific patient protocols, both diagnostic and therapeutic.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720460

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 080185, 08-H-0185
Study First Received: July 19, 2008
Last Updated: November 25, 2008
ClinicalTrials.gov Identifier: NCT00720460  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Magnetic Resonance Imaging
Minimally Invasive Therapy
Heart Catheterization
Healthy Volunteers
Gadolinium Contrast
Healthy Volunteer
HV

Study placed in the following topic categories:
Healthy

ClinicalTrials.gov processed this record on January 16, 2009