NCT05041296
Recruiting
Not Applicable
The Epileptic Heart - Multiparametric Cardiac Magnetic Resonance Imaging for Detection and Quantification of Acute and Chronic Cardiac Involvement in Patients With Epilepsy
University Hospital, Bonn2 sites in 1 country200 target enrollmentMarch 7, 2021
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Epilepsy
- Sponsor
- University Hospital, Bonn
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- T1 relaxation time
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
The aim of the study is to use multiparametric cardiac MRI to identify any abnormalities in myocardial structure and function in patients with epilepsy. A two-stage study design is planned as part of the study:
- In the acute setting, cardiac MRI will be performed in patients before and after a tonic-clonic seizure and compared intraindividually. In this study arm, potential acute seizure-induced myocardial damage will be detected.
- In the chronic setting, cardiac MRI will be performed in patients with known chronic epilepsy during the seizure-free interval to detect potential chronic myocardial damage (myocardial fibrosis) and compared with a control population. Within the group of epilepsy patients, possible associations with various epilepsy-specific characteristics (e.g., form, cause, onset, duration, and severity of epilepsy) will be investigated.
Investigators
Julian Alexander Luetkens
Principal Investigator, Senior Physician
University Hospital, Bonn
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
T1 relaxation time
Time Frame: Measurement will be performed within 2 weeks after MRI scan.
T1 relaxation times will be obtained to asses acute myocardial injury and fibrosis. T1 maps will be analyzed using a segmental approach by region of interest analysis. T1 relaxation times are given in \[ms\].
Secondary Outcomes
- T2 relaxation time(Measurement will be performed within 2 weeks after MRI scan.)
- Extracellular volume fraction(Measurement will be performed within 2 weeks after MRI scan.)
- Myocardial strain(Measurement will be performed within 2 weeks after MRI scan.)
Study Sites (2)
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