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

Primary Purpose

Transposition of the Great Arteries, Artery Switch Operation

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Transposition of the Great Arteries focused on measuring TGA, ASO, magnetic resonance imaging (MRI), young adulthood

Eligibility Criteria

18 Years - 28 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Aachen, Department od Pediatric CardiologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ASO group

Arm 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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
April 1, 2015
Last Updated
February 17, 2016
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT02415491
Brief Title
Cardiovascular MRI and Cardiopulmonary Exercise Capacity After Neonatal ASO) in Young Adults
Acronym
ASO
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transposition of the Great Arteries, Artery Switch Operation
Keywords
TGA, ASO, magnetic resonance imaging (MRI), young adulthood

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASO group
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ejection Fraction (EF)
Description
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.
Time Frame
up to 3 hours
Title
Heart rate (HR)
Description
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.
Time Frame
up to 3 hours
Title
Wall motion
Description
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.
Time Frame
up to 3 hours
Title
Pulmonary ventilation/pulmonary blood flow (V/Q in l/min)
Description
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.
Time Frame
up to 3 hours
Secondary Outcome Measure Information:
Title
Breathing minute volume (VE l/min)
Description
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.
Time Frame
up to 1 hour
Title
Peak oxygen uptake (VO2 in %)
Description
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.
Time Frame
up to 1 hour
Title
Forced vital capacity (in %)
Description
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.
Time Frame
up to 1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hedwig Hoevels- Guerich, Prof MD
Phone
+49 241 80
Ext
36253
Email
hhoevels-guerich@ukaachen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Habier, M. Sc.
Phone
+49 241 80
Ext
37429
Email
ahabier@ukaachen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hedwig Hoevels-Guerich, Prof MD
Organizational Affiliation
Department od Pediatric Cardiology, University Hospital Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aachen, Department od Pediatric Cardiology
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hedwig Hoevels-Guerich, Prof.
Phone
004924180
Ext
36253
Email
hhoevels-guerich@ukaachen.de
First Name & Middle Initial & Last Name & Degree
Angela Habier
Phone
004924180
Ext
37429
Email
ahabier@ukaachen.de

12. IPD Sharing Statement

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

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