Cardiovascular MRI and Cardiopulmonary Exercise Capacity After Neonatal ASO) in Young Adults

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Brief Title

Cardiovascular MRI and Cardiopulmonary Exercise Capacity After Neonatal ASO) in Young Adults

Official Title

Cardiovascular Magnetic Resonance at Rest and Stress in Relation to Cardiopulmonary Exercise Capacity in Young Adults After Arterial Switch Operation (ASO) for Transposition of the Great Arteries (TGA)

Brief Summary

      Magnetic Resonance Imaging of the heart at rest and stress conditions relative to the
      cardiopulmonary exercise capacity in young adults after neonatal surgery for transposition of
      the great arteries.
    

Detailed Description

      After ASO obstruction of the transposed coronary arteries with resulting reduced perfusion of
      the heart at stress or abnormities of the right ventricular blood flow resulting in
      increasing heart rate as well as abnormities in pulmonary flow can appear. In this single
      centre trial a large homogeneous group of young adults after surgery for transposition of the
      great arteries (TGA), the so called artery switch operation (ASO), will undergo magnetic
      resonance imaging (MRI) of the heart at rest and under drug- induced stress to receive data
      of the functional status of the heart and its perfusion as well as data of the pulmonary
      arterial perfusion.

      Also obstruction of the pulmonary arteries will lead to reduced perfusion and cardiopulmonary
      exercise capacity.

      Therefore the MRI data will be compared to cardiopulmonary exercise capacity data determined
      by cardio pulmonary stress test (CPX) concerning the feasibility of a correlation of the data
      and possible generalisation of the results leading to long term assessment of coronary
      perfusion and myocardial status after ASO for recommendations of physical activity of the
      young adults.
    


Study Type

Interventional


Primary Outcome

Ejection Fraction (EF)

Secondary Outcome

 Breathing minute volume (VE l/min)

Condition

Transposition of the Great Arteries

Intervention

Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test

Study Arms / Comparison Groups

 ASO group
Description:  ASO group:Evaluation of Correlation of Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test for long term assessment after ASO and recommendation of physical activity of young adults after TGA

Publications

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

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

100

Start Date

May 2015

Completion Date

November 2016

Primary Completion Date

November 2016

Eligibility Criteria

        Inclusion Criteria:

          -  former EMAH (adults with congenital heart defects) patients > 18 years old

          -  after neonatal ASO for TGA at the Department of pediatric cardiac surgery

          -  also if applicable with a correction of an aorta isthmus stenosis neotal or in infancy

        Exclusion Criteria:

          -  contraindications of MRI as metallic implants, claustrophobia

          -  contraindications of MRI contrast agents

          -  severe chronic kidney disease (estimated glomerular filtration rate < 30 ml/min)

          -  contraindications of exercise stress test with dobutamine or cardiopulmonary exercise
             stress test (e.g. instable angina pectoris, complex arrhythmia)

          -  disabled persons not able to perform cardiopulmonary exercise stress test

          -  pregnancy and breast feeding
      

Gender

All

Ages

18 Years - 28 Years

Accepts Healthy Volunteers

No

Contacts

Hedwig Hoevels-Guerich, Prof MD, +49 241 80, [email protected]

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT02415491

Organization ID

14-039


Responsible Party

Sponsor

Study Sponsor

RWTH Aachen University


Study Sponsor

Hedwig Hoevels-Guerich, Prof MD, Principal Investigator, Department od Pediatric Cardiology, University Hospital Aachen


Verification Date

February 2016