Myocardial Perfusion and Scarring in Congenital Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01639937
Recruitment Status : Suspended
First Posted : July 13, 2012
Last Update Posted : April 10, 2018
Children's Research Institute
Suburban Hospital
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Brief Summary:


- People with congenital heart disease may develop heart failure earlier that those who do not have the disease. One theory to explain this is that the heart s own blood supply may be different in people with congenital heart disease. Problems with this blood supply can severely damage the heart. This damage can be studied with a heart imaging test called a cardiac magnetic resonance imaging (MRI) scan. Researchers want to use this type of scan to look at the blood supply to the heart in people with congenital heart disease.


- To learn more about the blood supply to the heart in people with congenital heart disease.


- Individuals at least 18 years of age who have heart defects caused by congenital heart disease.


  • Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected.
  • Participants will have a cardiac MRI scan to look at the blood flow to the heart.
  • Participants will also have a heart stress test to measure heart function during exercise.
  • Other imaging studies of the heart may be performed to collect more information on heart function.

Condition or disease
Congenital Heart Disease

Detailed Description:
This is a study of the perfusion of the myocardium in adults with specific forms of repaired congenital heart disease using established cardiac MRI techniques and correlating perfusion with clinical outcomes. Our objectives are to examine myocardial perfusion both during stress and at rest in adults with repaired or palliated congenital heart disease as well as quantify ventricular function, regional myocardial strain and evidence of myocardial fibrosis with quantitative measures of myocardial perfusion. The specific aim of this study is to understand whether clinical subendocardial perfusion defects contribute to the late decompensation of adult subjects that have single ventricle physiology and adult subjects that have a systemic right ventricle.

Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Quantitative Myocardial Perfusion, Myocardial Scarring and Their Contribution to Late Clinical Decompensation in Adults With Congenital Heart Disease
Study Start Date : June 22, 2012

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Hypothesize that myocardial ischemia, as detectable by quantitative stress perfusion MRI, will predict systolic and diastolic dysfunction in subjects with single ventricle physiology and systemic right ventricles. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. A portion of ventricular systolic or diastolic dysfunction will be predictable based on myocardial fibrosis or scarring related to the underlying pathophysiology of single ventricle physiology & systemic right ventricles or post-surgical... [ Time Frame: 5 years ]
  2. Hypothesize that the combination of cardiac function, stress perfusion abnormalities and myocardial scarring/fibrosis will correlate with symptoms, NYHA functional class and BNP. [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria for All Arms of the Protocol:

  • Subjects 18 years of age or older
  • All defects that have a right ventricle that supports the systemic circulation
  • All defects with a functional single ventricle
  • Written informed consent


Exclusion Criteria for All Arms of the Protocol:

  • Subjects with a contraindication to MRI scanning will be excluded. These contraindications include subjects with the following devices:

    • Central nervous system aneurysm clips
    • Implanted neural stimulator
    • Implanted cardiac pacemaker or defibrillator
    • Cochlear implant
    • Ocular foreign body (e.g. metal shavings)
    • Implanted Insulin pump
    • Metal shrapnel or bullet
  • Severe heart damage that makes it difficult to breathe while lying flat
  • Pregnant women (Women of childbearing potential who are uncertain as to whether they are pregnant will be required to have a screening urine or blood pregnancy test)
  • Subjects with active symptoms of myocardial ischemia occurring despite maximally tolerated doses of oral antianginal therapy and intravenous nitroglycerin

Furthermore, the following subject groups will be excluded from studies involving the administration of MRI contrast agents:

  • lactating women unless they are willing to discard breast milk for 24 hours after receiving gadolinium
  • renal disease (estimated glomerular filtration rate [eGFR] < 30 ml/min/1.73 m2 body surface area)

The eGFR will be used to estimate renal function if reported by the laboratory. Otherwise, estimated glomerular filtration rate (eGFR) can be based on the Modification of Diet in Renal Disease (MDRD) study equation (see below) in subjects with stable renal function. This formula is not applicable to subjects with acute renal insufficiency:

eGFR (ml/min/1.73 m2) = 175 x (serum creatinine)-1.154 x (age)-0.203 x 0.742 (if the subject is female) x 1.212 (if the subject is black)

Additional Exclusion Criteria for Vasodilator Stress MRI:

  • Myocardial infarction within 24 hours
  • Uncontrolled heart failure
  • Uncontrolled asthma or emphysema
  • Ventricular arrhythmia (sustained ventricular arrhythmia at the time of MR scan)
  • Second degree heart block or higher

Information from the National Library of Medicine

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 identifier (NCT number): NCT01639937

United States, District of Columbia
Childrens National Medical Center
Washington, District of Columbia, United States
United States, Maryland
Suburban Hospital
Bethesda, Maryland, United States, 20814
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Children's Research Institute
Suburban Hospital
Principal Investigator: Andrew E Arai, M.D. National Heart, Lung, and Blood Institute (NHLBI)

Additional Information:
Responsible Party: National Heart, Lung, and Blood Institute (NHLBI) Identifier: NCT01639937     History of Changes
Other Study ID Numbers: 120158
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 6, 2018

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) ):
Cardiac MRI
Congestive Heart Failure
Cardiac Fibrosis
Late Gadolinium Enhancement

Additional relevant MeSH terms:
Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities