Myocardial Perfusion and Scarring in Congenital Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborators:
Children s National Medical Center
Suburban Hospital
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT01639937
First received: July 11, 2012
Last updated: May 15, 2014
Last verified: May 2014
  Purpose

Background:

- 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.

Objectives:

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

Eligibility:

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

Design:

  • 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
Congenital Heart Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Quantitative Myocardial Perfusion, Myocardial Scarring and Their Contribution to Late Clinical Decompensation in Adults With Congenital Heart Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 & amp; systemic right ventricles or post-surgic... [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: June 2012
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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:

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639937

Contacts
Contact: Marsha Block, R.N. (301) 496-0211 blockma@mail.nih.gov
Contact: Andrew E Arai, M.D. (301) 496-3658 araia@nih.gov

Locations
United States, District of Columbia
Childrens National Medical Center Recruiting
Washington, District of Columbia, United States
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Suburban Hospital Recruiting
Bethesda, Maryland, United States, 20814
Sponsors and Collaborators
Children s National Medical Center
Suburban Hospital
Investigators
Principal Investigator: Andrew E Arai, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT01639937     History of Changes
Other Study ID Numbers: 120158, 12-H-0158
Study First Received: July 11, 2012
Last Updated: May 15, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Cardiac MRI
Congestive Heart Failure
Cardiac Fibrosis
Late Gadolinium Enhancement

Additional relevant MeSH terms:
Cicatrix
Heart Diseases
Heart Defects, Congenital
Fibrosis
Pathologic Processes
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 26, 2014