Technical Development of Interventional Cardiovascular Magnetic Resonance Imaging in Normal Volunteers

NCT00720460 | Terminated

• 2 other identifiers: 08018508-H-0185
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Magnetic Resonance Imaging; Minimally Invasive Therapy; Transcatheter Therapeutics; Healthy Volunteers; Gadolinium Contrast; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• To develop and test new and incremental approaches to fast cardiovascular MRI in healthy human subjects. (healthy volunteers)

  There are 24 objectives listed in the protocol as potential outcomes.

  Day of study

Study Arms (1)

Experimental

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adult volunteers, age is greater than 18 years of age, who consent to participate in writing

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Lederman RJ. Cardiovascular interventional magnetic resonance imaging. Circulation. 2005 Nov 8;112(19):3009-17. doi: 10.1161/CIRCULATIONAHA.104.531368. No abstract available.

  PMID: 16275886 BACKGROUND

• Haustein J, Laniado M, Niendorf HP, Louton T, Beck W, Planitzer J, Schoffel M, Reiser M, Kaiser W, Schorner W, et al. Triple-dose versus standard-dose gadopentetate dimeglumine: a randomized study in 199 patients. Radiology. 1993 Mar;186(3):855-60. doi: 10.1148/radiology.186.3.8430199.

  PMID: 8430199 BACKGROUND

• 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. doi: 10.1002/mrm.1910220212.

  PMID: 1812350 BACKGROUND

• Saybasili H, Kellman P, Griswold MA, Derbyshire JA, Guttman MA. HTGRAPPA: real-time B1-weighted image domain TGRAPPA reconstruction. Magn Reson Med. 2009 Jun;61(6):1425-33. doi: 10.1002/mrm.21922.

  PMID: 19353673 DERIVED

Study Officials

• Robert J Lederman, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2008
• First Posted: July 22, 2008
• Study Start: July 18, 2008
• Study Completion: November 2, 2018
• Last Updated: December 16, 2019

Record last verified: 2018-11-02

Locations

US (1)