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

NCT ID: NCT02415491

Last Updated: 2016-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-11-30

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.

Conditions

Transposition of the Great Arteries; Artery Switch Operation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

ASO group

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of pulmonary perfusion.

Afterwards induced stress MRI will be performed according to standard protocol with elevation of dobutamine levels until the reach of peak HR. If applicable the procedure will be stopped) in case of e.g. arrhythmia.

Cardiopulmonary exercise stress test will be performed; patient will sit at rest on the ergometer, the subject's gas exchange will be recorded; with the pedal speed constant, the resistance will be increased from 0.5 watt/kg to 3 watt/kg over 10 minutes. Electrocardiography and heart rate will be taken continuously during and until 10 minutes afterwards. Blood pressure will be taken before, during and after the stress test. Respiratory gas exchange parameters will be taken continuously, peak oxygen uptake (VO2) determined as well as Ventilatory Efficiency.

Interventions

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

MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of pulmonary perfusion.

Afterwards induced stress MRI will be performed according to standard protocol with elevation of dobutamine levels until the reach of peak HR. If applicable the procedure will be stopped) in case of e.g. arrhythmia.

Cardiopulmonary exercise stress test will be performed; patient will sit at rest on the ergometer, the subject's gas exchange will be recorded; with the pedal speed constant, the resistance will be increased from 0.5 watt/kg to 3 watt/kg over 10 minutes. Electrocardiography and heart rate will be taken continuously during and until 10 minutes afterwards. Blood pressure will be taken before, during and after the stress test. Respiratory gas exchange parameters will be taken continuously, peak oxygen uptake (VO2) determined as well as Ventilatory Efficiency.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 28 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hedwig Hoevels-Guerich, Prof MD

Role: PRINCIPAL_INVESTIGATOR

Department od Pediatric Cardiology, University Hospital Aachen

Locations

University Hospital Aachen, Department od Pediatric Cardiology

Aachen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Hedwig Hoevels- Guerich, Prof MD

Role: CONTACT

hhoevels-guerich@ukaachen.de

+49 241 80 ext. 36253

Angela Habier, M. Sc.

Role: CONTACT

ahabier@ukaachen.de

+49 241 80 ext. 37429

Facility Contacts

Hedwig Hoevels-Guerich, Prof.

Role: primary

hhoevels-guerich@ukaachen.de

004924180 ext. 36253

Angela Habier

Role: backup

ahabier@ukaachen.de

004924180 ext. 37429

Other Identifiers

14-039

Identifier Type: -

Identifier Source: org_study_id