Cerebral Perfusion and Flow Pulsatility in Patients with Aortic Coarctation * a 7 Tesla MRI Study

Completed

• Conditions: Aortic coarctation; narrowing of the aorta; 10010394; 10007963

• Registration Number: NL-OMON48005
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-11-06
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Patients:
- Subject has been diagnosed with CoA.
- Subject has previously undergone surgical treatment or balloon dilatation for
CoA.
- Subject is 12 years or older.
- Subject is competent to understand the performed procedures, the potential
hazards associated with these procedures, and to provide written informed
consent.

Controls:
- Subject is 12 years or older.
- Subject is competent to understand the performed procedures, the potential
hazards associated with these procedures, and to provide written informed
consent.

Exclusion Criteria

Patients:
- Subject is currently pregnant.
- Subject has previously undergone stent implantation for CoA.
- Subject has undergone a cardiovascular intervention between the 7T MRI brain
and the combined 3T MRI brain and 3T cardiac MRI, which, in the opinion of the
investigator, could adversely affect the interpretation of the results.
- Subject has a medical condition which, in the opinion of the investigator,
could adversely affect the subject*s safety and/or the interpretation of the
results.
- Subject with a contraindication for MRI:
o Cardiac pacemaker or implanted cardioverter defibrillator not compatible with
MRI.
o Electronic device or implant, such as cochlear implant or insulin pump.
o Known claustrophobia.

Controls:
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Subject has a history of aortic coarctation or other cardiovascular disease.
- Subject has a history of neurological disease or intellectual disability.
- Subject is currently pregnant.
- Subject has a medical condition which, in the opinion of the investigator,
could adversely affect the subject*s safety and/or the interpretation of the
results.
- Subject with a contraindication for MRI:
o Cardiac pacemaker or implanted cardioverter defibrillator not compatible with
MRI.
o Electronic device or implant, such as cochlear implant or insulin pump.
o Known claustrophobia.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters in this study are flow pulsatility index and mean<br /><br>flow velocity of the large and perforating cerebral arteries, quantity of<br /><br>ischemic white matter lesions, and quantity of cerebral microbleeds.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Systemic blood pressure by right arm, left arm, and right leg cuff<br /><br>measurements.<br /><br>- Systemic blood pressure by right arm 24-hour ambulatory blood pressure<br /><br>monitoring (only in CoA patients).<br /><br>- Left ventricular ejection fraction.<br /><br>- Left ventricular mass.<br /><br>- Aortic pulse wave velocity.<br /><br>- Distensibility of ascending aorta.<br /><br>- Aortic diameter at CoA site and diaphragm level.<br /><br>- Clinical symptoms at baseline interview: symptoms suggestive of TIA or<br /><br>stroke, headache, migraine.</p><br>