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Clinical Trials/NCT05041296
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:

  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.
Registry
clinicaltrials.gov
Start Date
March 7, 2021
End Date
December 31, 2024
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bonn
Responsible Party
Principal Investigator
Principal Investigator

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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