Safety and Effectiveness of Coronary Magnetic Resonance Angiography (CMRA) Imaging

March 3, 2008 updated by: National Heart, Lung, and Blood Institute (NHLBI)

A Phase II Feasibility Study of the Safety and Efficacy of Coronary Magnetic Resonance Angiography (CMRA) Imaging

Magnetic resonance imaging (MRI) is a diagnostic tool that creates high quality images of the human body without the use of X-ray (radiation). MRI is especially useful when studying the arteries of the heart (CMRA, coronary magnetic resonance angiography).

In this study researchers from several laboratories and hospitals will work together to determine the safety and effectiveness of CMRA with MS-325. MS-325 is a contrast agent. It is given to patients undergoing CRMA in order to improve the appearance of the arteries of the heart.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this multicenter trial, the safety and efficacy of magnetic resonance imaging (MRI) for visualization of the coronary arteries (CMRA, coronary magnetic resonance angiography) with MS-325. MS-325 is a new blood pool radiological contrast agent which will be assessed as part of a phase II feasibility study. The Laboratory of Cardiac Energetics in collaboration with the Department of Cardiology at the George Washington Hospital Center will be one of the six participating sites for this study.

Study Type

Interventional

Enrollment

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Heart, Lung and Blood Institute (NHLBI)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Male or female greater than or equal to 18 years of age.

Body weight less than or equal to 120 kg.

If female, be surgically sterile for at least one year, be post-menopausal for at least one year, or test negative on a pregnancy test by urine or blood within 48 hours prior to MS-325 administration.

Ability to comprehend and a willingness to sign an Informed Consent Form.

Stable medical condition at time of MS-325 administration with no major clinical cardiovascular events within 30 days of MS-325 administration.

Fasted from liquids and solids for two hours prior to MS-325 administration.

Must have a positive diagnostic quality coronary x-ray angiogram which demonstrated coronary artery stenosis(es) of at least 50 percent diameter stenosis in at least one proximal coronary artery vessel between five and 30 days prior to MS-325 administration; angiographic data must be available for loan to an angiographic core lab in order for the patient to be included in the trial.

Normal sinus rhythm.

Willing to abstain from alcohol from 24 hours prior to MS-325 administration through 72-96 hours following MS-325 administration.

No prior coronary bypass graft or coronary stent of the target vessel.

No acute or chronic condition which would limit the patient's ability to complete the study.

No history of claustrophobia.

No receipt of any investigational drug within 30 days prior to

MS-325 administration.

No previous exposure to MS-325; no previous exposure to other contrast agents in other contrast enhanced MR or x-ray studies within five days prior to MS-325 administration.

No major clinical cardiovascular events, coronary angioplasty, or major surgery within 30 days prior to MS-325 administration.

No scheduled x-ray angiography within five days prior to MS-325 administration.

No supine blood pressure less than 100/60 mm HG with pulse rate less than 50 beats per minute (bpm), or supine blood pressure greater than 160/100 m HG with pulse rate greater than 100 bpm, unless deemed not clinically significant by the Principal Investigator.

No history of involuntary motion disorder.

No persons unable to lay on back for 120 minutes.

No persons with known serum creatinine levels greater than 1.5 mg/dL or clinical evidence of severe renal impairment; serum creatinine levels must be determined at least 72 hours post-x-ray angiography but prior to MS-325 administration.

No known SGPT (ALT) and SGOT (AST) levels exceeding three times the upper limit of the study center's normal range; no known serum bilirubin greater than 1.75 mg/dL or clinical evidence of severe hepatic disease.

No specific magnetic resonance (MR) exclusion criteria (i.e., pacemaker, ear implants, internal defibrillator, internal defibrillator, internal infusion pump), as well as institution-specific requirements.

No metal implants or clips in field of view (FOV).

No female who is pregnant or currently lactating.

No recent history of clinically significant anemia (less than or equal to 8.0 g/dL).

No history of sickle cell anemia.

No clinical suspicion of worsening in vascular status of target artery between time of x-ray angiogram and MS-325 administration.

Not received warfarin within seven days prior to MS-325 administration.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1997

Study Completion

December 1, 2000

Study Registration Dates

First Submitted

November 3, 1999

First Submitted That Met QC Criteria

December 9, 2002

First Posted (Estimate)

December 10, 2002

Study Record Updates

Last Update Posted (Estimate)

March 4, 2008

Last Update Submitted That Met QC Criteria

March 3, 2008

Last Verified

December 1, 1999

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 970193
  • 97-H-0193

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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