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

Recruiting

• Conditions: Epilepsy; Cardiomyopathies
• Interventions: Diagnostic Test: Cardiac magnetic resonance scan

• Registration Number: NCT05041296
• Lead Sponsor: University Hospital, Bonn

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:

1. 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.

2. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-07
• Study First Submitted: 2021-08-27
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-07
• Last Update Submitted: 2021-09-07
• Study First Posted: 2021-09-13
• Last Update Posted: 2021-09-13
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute group	Cardiac magnetic resonance scan	Epilepsy and short-term history of seizures
Control group	Cardiac magnetic resonance scan	Healthy participants
Chronic group	Cardiac magnetic resonance scan	Chronic epilepsy with recurrent seizures

Primary Outcome Measures

Name	Time	Method
T1 relaxation time	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 Outcome Measures

Name	Time	Method
T2 relaxation time	Measurement will be performed within 2 weeks after MRI scan.	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 \[ms\].
Extracellular volume fraction	Measurement will be performed within 2 weeks after MRI scan.	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 \[%\].
Myocardial strain	Measurement will be performed within 2 weeks after MRI scan.	Cardiac magnetic resonance feature-tracking will be used to asses left ventricular longitudinal, circumferential and radial strain (Strain values are given in \[%\]).

Trial Locations

Locations (2)

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology; 🇩🇪 Bonn, NRW, Germany

University Hospital Bonn, Clinic and Polyclinic for Epileptology; 🇩🇪 Bonn, NRW, Germany