Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques

Brief Title

Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques

Official Title

Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques

Brief Summary

      The investigators are beginning a clinical research study here at UCSF to learn more about
      how hearts with single ventricles work. The investigators hypothesize that myocardial strain
      , as measured by cardiac MRI,in patients with single ventricles differs from normal hearts.
      This abnormality is associated with depressed cardiac power output and impaired exercise
      capacity. The study will utilize cardiac magnetic resonance imaging, exercise testing, and
      lung function testing to study how the single ventricle heart works so that in the future the
      investigators can improve how the investigators care for patients with this type of
      congenital heart disease.

      The research protocol involves: Cardiac magnetic resonance imaging (MRI of the heart),
      exercise tests, and lung function tests. Some of these tests are routinely used to follow
      patients with single ventricles. Some of these tests are part of the research protocol. If
      you agree to participate in this study, these tests will be performed at UCSF. The results of
      the routine tests will be shared with your doctor.

      Participation will require approximately 30 additional minutes to the cardiac MRI procedure
      to collect the research data. The exercise tests, and lung function tests time commitment
      will take about two hours.
    



Study Type

Observational


Primary Outcome

Global and regional myocardial strain (radial, longitudinal and circumferential) as measured by cardiac MRI.


Condition

Fontan Procedure


Study Arms / Comparison Groups

 Single right ventricles
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

13

Start Date

November 2009

Completion Date

September 20, 2012

Primary Completion Date

September 20, 2012

Eligibility Criteria

        Inclusion Criteria:

          -  Anatomy: The investigators will enroll 10 patients with single right ventricles status
             post Fontan and 10 patients with single left ventricles status post Fontan.

          -  Age range: 5 patients in each group will be between the ages of 10-18 years of age and
             5 patients in each group will be older than 18 years of age.

        Exclusion Criteria:

          -  Study subjects will be excluded if there are any contraindications to MRI including
             permanent pacemaker, ICD, retained permanent wires, cerebral aneurysm clips,
             neurostimulators, insulin or infusion pumps, implanted drug infusion devices, bone
             growth/fusion stimulators, or cochlear implants.

          -  In addition, patients with implanted hardware that may lead to inadequate imaging,
             such as steel coils or ventricular septal defect occluder devices, will be excluded.

          -  Finally, patients with developmental delay or physical limitations precluding
             cooperation with the MRI or exercise test or patients with claustrophobia will be
             excluded. Patients will be asked if there is any chance that they are pregnant. If
             they are possibly pregnant, they will be excluded.
      

Gender

All

Ages

10 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Alexander Lowenthal, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01107990

Organization ID

H64391-34645-01


Responsible Party

Sponsor

Study Sponsor

University of California, San Francisco


Study Sponsor

Alexander Lowenthal, MD, Principal Investigator, University of California, San Francisco


Verification Date

January 2020