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Cardiac DiseaseNCT02861365

Myocardial Perfusion and Scarring in Adults With Congenital Heart Disease

An observational study of Cardiac Disease, run by Children's National Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Disease
How many people
18 participants
Where
1 siteUnited States
Study dates
Jul 2013to 18 Jan 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Primary care clinic

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's National Health System

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: Quantitative Myocardial Perfusion, Myocardial Scarring and Their Contribution to Late Clinical Decompensation in Adults With Congenital Heart Disease

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.

Read the 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.

Conditions
Cardiac Disease
Medical subject headings
Heart Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Myocardial Ischemia measuring coronary perfusion reserve.

    Compare quantitative myocardial perfusion at stress and rest with measures of systolic and diastolic function in exams performed in close temporal proximity.

    Measured: 5 years

  2. Myocardial Ischemia measuring ejection fraction.

    Compare the extent of myocardial ischemia through ejection fraction measurement of the systemic ventricle.

    Measured: 5 years

  3. Myocardial Ischemia measuring heart inflow Doppler.

    Compare heart inflow Doppler of the systemic atrioventricular valve to understand the extent of myocardial ischemia.

    Measured: 5 years

Secondary outcomes (5)

  1. Scarring and fibrosis by measuring Late Gadolinium Enhancement results.

    Directly compare the extent of myocardial scarring/fibrosis with echo-derived measures of systolic and diastolic function.

    Measured: 5 years

  2. Scarring and fibrosis by measuring systolic and diastolic function.

    Compare the extent of myocardial scarring/fibrosis with echo-derived measures of systolic and diastolic function.

    Measured: 5 years

  3. Comparison of MRI measurements with blood test.

    Number of participants with predictable future heart failure symptom will be assessed by comparing all cardiac MRI exam measurements with blood test.

    Measured: 5 years

  4. Comparison of MRI measurements with walk test.

    Number of participants with predictable future heart failure symptom will be assessed by comparing all cardiac MRI exam measurements with walk test.

    Measured: 5 years

  5. Comparison of MRI measurements with NY Heart Association class

    Number of participants with predictable future heart failure symptom will be assessed by comparing all cardiac MRI exam measurements with NY Heart Association class.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2016 (estimated)
  2. Study startJul 2013
  3. Primary completion18 Jan 2020
  4. Study completion18 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02861365
Sponsor's protocol ID
Pro00003067
Other IDs
contract
Status last verified
Mar 2021
First submitted
12 Jul 2016
Last updated
5 Mar 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Results of MRI scans will be shared with the primary cardiologist.

Publications

  • Verheugt CL, Uiterwaal CS, van der Velde ET, Meijboom FJ, Pieper PG, van Dijk AP, Vliegen HW, Grobbee DE, Mulder BJ. Mortality in adult congenital heart disease. Eur Heart J. 2010 May;31(10):1220-9. doi: 10.1093/eurheartj/ehq032. Epub 2010 Mar 5.

    PubMed 20207625

  • Rutledge JM, Nihill MR, Fraser CD, Smith OE, McMahon CJ, Bezold LI. Outcome of 121 patients with congenitally corrected transposition of the great arteries. Pediatr Cardiol. 2002 Mar-Apr;23(2):137-45. doi: 10.1007/s00246-001-0037-8. Epub 2002 Feb 19.

    PubMed 11889523

  • Meijboom F, Szatmari A, Deckers JW, Utens EM, Roelandt JR, Bos E, Hess J. Long-term follow-up (10 to 17 years) after Mustard repair for transposition of the great arteries. J Thorac Cardiovasc Surg. 1996 Jun;111(6):1158-68. doi: 10.1016/s0022-5223(96)70217-9.

    PubMed 8642816

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Disease, run by Children's National Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myocardial Ischemia measuring coronary perfusion reserve. (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02861365, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.

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