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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON48005
Enrollment
50
Registered
2019-07-31
Start date
2019-10-01
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic coarctation narrowing of the aorta

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
12 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The main study parameters in this study are flow pulsatility index and mean flow velocity of the large and perforating cerebral arteries, quantity of ischemic white matter lesions, and quantity of cerebral microbleeds.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)