Validation of MRI Measurement of Cardiac Blood Flow

June 30, 2017 updated by: National Heart, Lung, and Blood Institute (NHLBI)

Validation of Cardiac MR Perfusion With Cardiac Catheterization Physiological Assessment

This study will test the accuracy of magnetic resonance imaging (MRI) in measuring cardiac perfusion (blood flow). MRI of the heart can measure blood flow to heart muscle, but collateral coronary arteries (vessels that supply blood to the heart muscle) may reduce the accuracy of the measurements. This study will perform special measurements of coronary artery flow and pressure in patients undergoing heart catheterization and catheter-based treatment (angioplasty and stenting) in order to compare for accuracy with cardiac MRI.

Patients 21 years of age and older with coronary artery blockage may be eligible for this study. All participants undergo cardiac MRI, to produce images of the heart, as well as special invasive blood flow testing during heart catheterization, angioplasty, and stenting.

During MRI, the subject lies on a table that can slide in and out of the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 45 to 90 minutes. Since the heart moves during breathing, subjects are asked to hold their breath intermittently for about 5-20 seconds. A medicine called dipyridamole is injected through a vein in the subject's arm to increase blood flow to the coronary arteries and help detect blockages. Pictures are taken of the heart before, during, and after the dipyridamole injection. Another medicine called gadolinium is also given through a vein. This medicine brightens the images to measure blood flow.

During a separate catheterization, angioplasty, and stenting procedure, subjects undergo additional invasive tests. The additional tests use a special guidewire to measure coronary artery pressure and blood flow, as well as a special ultrasound to look inside the artery.

Patients have a repeat MRI about 2 months after the catheterization.

Study Overview

Status

Completed

Conditions

Detailed Description

Cardiac magnetic resonance imaging (MRI) can measure perfusion (blood flow) to heart muscle. Collateral coronary arteries (natural bypasses to the heart) may reduce the accuracy of perfusion measured by cardiac MRI.

We are testing the accuracy of these measurements in subjects undergoing medically necessary cardiac catheterization and catheter-based treatment (angioplasty and stenting). We will perform special invasive measurements of coronary artery flow and pressure during catheterization in order to compare with cardiac MRI.

Study Type

Observational

Enrollment (Actual)

34

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 Institutes of Health Clinical Center, 9000 Rockville Pike

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • INCLUSION CRITERIA:
  • Patients with known or suspected cardiovascular disease
  • Age above age 21 (coronary artery disease is rare in subjects less than age 21)
  • Undergoing medically necessary coronary arteriography
  • Written informed consent
  • The subject must allow access to the use of previous medical information from NIH or any institution in order to participate in the research study.

EXCLUSION CRITERIA:

Medical Exclusion Criteria:

  • Pregnant women (when uncertain, subjects will undergo urine or blood testing) or lactating women
  • Decompensated congestive heart failure (unable to lie flat during MRI or catheterization)
  • Impaired renal excretory function (calculated Glomerular Filtration Rate less than 30mL/min/1.73m(2)) unless on dialysis.

MRI Exclusion Criteria (for MRI scan only):

  • Cardiac pacemaker or implantable defibrillator
  • Cerebral aneurysm clip
  • Neural stimulator (e.g. TENS-Unit)
  • Any type of ear implant
  • Ocular foreign body (e.g. metal shavings)
  • Any implanted device (e.g. insulin pump, drug infusion device)
  • Metal shrapnel or bullet.

Unable to tolerate dipyridamole:

-Reactive airways disease (significant asthma or chronic obstructive pulmonary disease and unable to tolerate a beta adrenergic antagonist).

Post-Hoc Catheterization Exclusion Criteria (determined during coronary arteriography):

  • Excessive tortuosity or any angiographic features that, in the opinion of catheterization operator, would make invasive physiology assessments unsafe or unsuitable
  • Ongoing myocardial ischemia or other exigency that would make further study participation hazardous
  • Normal epicardial coronary arteries and normal perfusion cardiac MRI

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

Collaborators and Investigators

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

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 29, 2006

Study Completion

July 19, 2010

Study Registration Dates

First Submitted

December 30, 2006

First Submitted That Met QC Criteria

January 3, 2007

First Posted (Estimate)

January 4, 2007

Study Record Updates

Last Update Posted (Actual)

July 2, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

July 19, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 070056
  • 07-H-0056

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.

Clinical Trials on Coronary Artery Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe