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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Cardiomyopathies
• Intervention / Treatment: Diagnostic test: Cardiac magnetic resonance scan

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Julian A. Luetkens, PD Dr.; Phone Number: +49 228 287 19860; Email: julian.luetkens@ukbonn.de
• Study Contact Backup: Name: Alexander Isaak, Dr.; Phone Number: +49 228 287 15960; Email: alexander.isaak@ukbonn.de

Study Locations

• Germany
  • NRW
    • Bonn, NRW, Germany, 53127
      • Recruiting
      • University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
    • Bonn, NRW, Germany, 53127
      • Recruiting
      • University Hospital Bonn, Clinic and Polyclinic for Epileptology
      • Contact: Rainer Surges, Prof.; Phone Number: +49 228 287 15727; Email: rainer.surges@ukbonn.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with epilepsy with treatment in the Clinic and Polyclinic for Epileptology of the University Hospital Bonn (Primary care clinic)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic group; Chronic epilepsy with recurrent seizures	Diagnostic test: Cardiac magnetic resonance scan; Multiparametric cardiac magnetic resonance including traditional and quantitative functional and structural parameters
Acute group; Epilepsy and short-term history of seizures	Diagnostic test: Cardiac magnetic resonance scan; Multiparametric cardiac magnetic resonance including traditional and quantitative functional and structural parameters
Control group; Healthy participants	Diagnostic test: Cardiac magnetic resonance scan; Multiparametric cardiac magnetic resonance including traditional and quantitative functional and structural parameters

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: August 27, 2021
• First Submitted That Met QC Criteria: September 7, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Cardiomyopathies
• Other Study ID Numbers: 534/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No