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

RWTH Aachen University

Status: Unknown

Conditions: Transposition of the Great Arteries; Artery Switch Operation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02415491

14-039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 28 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

ASO group

Experimental 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

Treatment:

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