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

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)

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.

Study Overview

• Status: Unknown
• Conditions: Transposition of the Great Arteries; Artery Switch Operation
• Intervention / Treatment: Other: Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test

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
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hedwig Hoevels- Guerich, Prof MD; Phone Number: 36253 +49 241 80; Email: hhoevels-guerich@ukaachen.de
• Study Contact Backup: Name: Angela Habier, M. Sc.; Phone Number: 37429 +49 241 80; Email: ahabier@ukaachen.de

Study Locations

• Germany
  • Aachen, Germany, 52074
    • Recruiting
    • University Hospital Aachen, Department od Pediatric Cardiology
    • Contact: Hedwig Hoevels-Guerich, Prof.; Phone Number: 36253 004924180; Email: hhoevels-guerich@ukaachen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ejection Fraction (EF)	MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of the ejection fraction. Afterwards induced stress MRI will be performed according to standard protocol, with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.	up to 3 hours
Heart rate (HR)	MRI at rest will be performed, afterwards induced stress MRI will be performed according to standard protocol, with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.	up to 3 hours
Wall motion	MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of wall motions. Induced stress MRI will be performed according to standard protocol, with elevation of dobutamine levels every 3 minutes from 10 microgram /kg/min to 40 microgram until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.	up to 3 hours
Pulmonary ventilation/pulmonary blood flow (V/Q in l/min)	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 every 3 minutes from 10 microgram /kg/min to 40 microgram/kg/min until the reach of peak HR. If applicable the procedure will be stopped in case of e.g. arrhythmia.	up to 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breathing minute volume (VE l/min)	cardiopulmonary exercise stress test will be performed; patient will sit at rest on the ergometer and 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.	up to 1 hour
Peak oxygen uptake (VO2 in %)	cardiopulmonary exercise stress test will be performed; patient will sit at rest on the ergometer and the subject's gas exchange will be recorded; with the pedal speed constant, the resistance will be increased from 0.5 watt/kg t0 3 watts/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 VO2 determined.	up to 1 hour
Forced vital capacity (in %)	cardiopulmonary exercise stress test will be performed; patient will sit at rest on the ergometer and the subject's gas exchange will be recorded; with the pedal speed constant, the resistance will be increased from 0.5 watt/kg t0 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, forced vital capacity determined.	up to 1 hour

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Hedwig Hoevels-Guerich, Prof MD, Department od Pediatric Cardiology, University Hospital Aachen

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Anticipated): November 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: April 1, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Estimate): February 18, 2016
• Last Update Submitted That Met QC Criteria: February 17, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: TGA; ASO; magnetic resonance imaging (MRI); young adulthood
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Transposition of Great Vessels
• Other Study ID Numbers: 14-039

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No