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Myocardial Perfusion and Scarring in Adults With Congenital Heart Disease

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ClinicalTrials.gov Identifier: NCT02861365
Recruitment Status : Active, not recruiting
First Posted : August 10, 2016
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Laura Olivieri, Children's National Research Institute

Brief Summary:
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.

Condition or disease
Cardiac 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. The investigators 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.

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Study Type : Observational
Estimated Enrollment : 20 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 : July 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Myocardial Ischemia measuring coronary perfusion reserve. [ Time Frame: 5 years ]
    Compare quantitative myocardial perfusion at stress and rest with measures of systolic and diastolic function in exams performed in close temporal proximity.

  2. Myocardial Ischemia measuring ejection fraction. [ Time Frame: 5 years ]
    Compare the extent of myocardial ischemia through ejection fraction measurement of the systemic ventricle.

  3. Myocardial Ischemia measuring heart inflow Doppler. [ Time Frame: 5 years ]
    Compare heart inflow Doppler of the systemic atrioventricular valve to understand the extent of myocardial ischemia.


Secondary Outcome Measures :
  1. Scarring and fibrosis by measuring Late Gadolinium Enhancement results. [ Time Frame: 5 years ]
    Directly compare the extent of myocardial scarring/fibrosis with echo-derived measures of systolic and diastolic function.

  2. Scarring and fibrosis by measuring systolic and diastolic function. [ Time Frame: 5 years ]
    Compare the extent of myocardial scarring/fibrosis with echo-derived measures of systolic and diastolic function.

  3. Comparison of MRI measurements with blood test. [ Time Frame: 5 years ]
    Number of participants with predictable future heart failure symptom will be assessed by comparing all cardiac MRI exam measurements with blood test.

  4. Comparison of MRI measurements with walk test. [ Time Frame: 5 years ]
    Number of participants with predictable future heart failure symptom will be assessed by comparing all cardiac MRI exam measurements with walk test.

  5. Comparison of MRI measurements with NY Heart Association class [ Time Frame: 5 years ]
    Number of participants with predictable future heart failure symptom will be assessed by comparing all cardiac MRI exam measurements with NY Heart Association class.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

  • 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:

  • Subjects with a contraindication to magnetic resonance imaging (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 ClinicalTrials.gov identifier (NCT number): NCT02861365


Locations
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United States, District of Columbia
Children's National Health System
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Children's National Research Institute
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Laura Olivieri, MD Children's National Health Systems

Publications:
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Responsible Party: Laura Olivieri, MD, Children's National Research Institute
ClinicalTrials.gov Identifier: NCT02861365    
Other Study ID Numbers: Pro00003067
contract ( Other Identifier: NIH )
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results of MRI scans will be shared with the primary cardiologist.
Supporting Materials: Clinical Study Report (CSR)
Time Frame: MRI report becomes available once the scan has been assessed, usually within 24 hours. It will be available indefinitely.
Access Criteria: Primary care takers will have access to this report.
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases