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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05041296
• Other study ID #: 534/20
• Status: Recruiting
• Start date: March 7, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2021
• Source: University Hospital, Bonn
• Contact: Julian A. Luetkens, PD Dr.
• Phone: +49 228 287 19860
• Email: julian.luetkens[@]ukbonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria:

1. diagnosed epilepsy

2. examination under usual antiepileptic pharmacotherapy or medication up-dosing (if medication was reduced during video-EEG recording)

3. age between 18-60 years

Exclusion criteria:

1. underlying cardiac disease, e.g. coronary artery disease, previous myocardial infarction, previous myocarditis, complex congenital heart defect, known cardiomyopathy of other cause

2. pregnant and breastfeeding women

3. patients who use IUD for contraception

4. patients with a contraindication to contrast enhanced MRI

Related Conditions & MeSH terms

• Cardiomyopathies
• Epilepsy

Intervention

Diagnostic Test:
• Cardiac magnetic resonance scan
Multiparametric cardiac magnetic resonance including traditional and quantitative functional and structural parameters

Locations

Country	Name	City	State
Germany	University Hospital Bonn, Clinic and Polyclinic for Epileptology	Bonn	NRW
Germany	University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology	Bonn	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.