Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Normal Volunteers
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ClinicalTrials.gov Identifier: NCT00720460 |
Recruitment Status
:
Recruiting
First Posted
: July 22, 2008
Last Update Posted
: March 29, 2018
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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 or disease |
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Healthy |
Study Type : | Observational |
Estimated Enrollment : | 250 participants |
Observational Model: | Case-Only |
Time Perspective: | Prospective |
Official Title: | Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Healthy Volunteers |
Study Start Date : | July 18, 2008 |

Group/Cohort |
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Experimental
Healthy Volunteers
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- To develop and test new and incremental approaches to fast cardiovascular MRI in healthy human subjects. (healthy volunteers) [ Time Frame: Day of study ]There are 24 objectives listed in the protocol as potential outcomes.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
- 1. GENERAL INCLUSION CRITERIA:
-
Healthy 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720460
Contact: Annette Stine, R.N. | (301) 402-5558 | stinea@nhlbi.nih.gov | |
Contact: Robert J Lederman, M.D. | (301) 402-6769 | lederman@nih.gov |
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 prpl@cc.nih.gov |
Principal Investigator: | Robert J Lederman, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00720460 History of Changes |
Other Study ID Numbers: |
080185 08-H-0185 |
First Posted: | July 22, 2008 Key Record Dates |
Last Update Posted: | March 29, 2018 |
Last Verified: | February 1, 2018 |
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Magnetic Resonance Imaging Minimally Invasive Therapy Transcatheter Therapeutics Healthy Volunteers |
Gadolinium Contrast Healthy Volunteer HV |