Cardiac MRI for Detection of Acute and Chronic Cardiac Involvement in Patients With Epilepsy

Study Overview
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Brief Summary
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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.

Official Title
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The Epileptic Heart - Multiparametric Cardiac Magnetic Resonance Imaging for Detection and Quantification of Acute and Chronic Cardiac Involvement in Patients With Epilepsy

Conditions
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Epilepsy, Cardiomyopathies

Intervention / Treatment
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* Diagnostic Test: Cardiac magnetic resonance scan


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: diagnosed epilepsy examination under usual antiepileptic pharmacotherapy or medication up-dosing (if medication was reduced during video-EEG recording) age between 18-60 years Exclusion criteria: underlying cardiac disease, e.g. coronary artery disease, previous myocardial infarction, previous myocarditis, complex congenital heart defect, known cardiomyopathy of other cause pregnant and breastfeeding women patients who use IUD for contraception patients with a contraindication to contrast enhanced MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic group<br>Chronic epilepsy with recurrent seizures | Diagnostic Test: Cardiac magnetic resonance scan<br>* Multiparametric cardiac magnetic resonance including traditional and quantitative functional and structural parameters<br>|
| Acute group<br>Epilepsy and short-term history of seizures | Diagnostic Test: Cardiac magnetic resonance scan<br>* Multiparametric cardiac magnetic resonance including traditional and quantitative functional and structural parameters<br>|
| Control group<br>Healthy participants | Diagnostic Test: Cardiac magnetic resonance scan<br>* Multiparametric cardiac magnetic resonance including traditional and quantitative functional and structural parameters<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T1 relaxation time | 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]. | Measurement will be performed within 2 weeks after MRI scan. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T2 relaxation time | T2 relaxation times will be obtained to asses myocardial edema. T2 maps will be analyzed using a segmental approach by region of interest analysis. T2 relaxation times are given in [ms]. | Measurement will be performed within 2 weeks after MRI scan. | 
| Extracellular volume fraction | Myocardial extracellular volume will be obtained to asses extracellular space/myocardial fibrosis. ECV values will be calculated using a segmental approach by region of interest analysis of native and contrast-enhanced T1 relaxation maps. ECV values are given in [%]. | Measurement will be performed within 2 weeks after MRI scan. | 
| Myocardial strain | Cardiac magnetic resonance feature-tracking will be used to asses left ventricular longitudinal, circumferential and radial strain (Strain values are given in [%]). | Measurement will be performed within 2 weeks after MRI scan. |