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

• Sponsor: University Hospital, Bonn (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05041296
• Collaborator: (none)
• Enrollment: 200
• Locations: 2
• Anticipated Duration (Months): 45.8
• Patients Per Site: 100
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy; Cardiomyopathies	Diagnostic Test: Cardiac magnetic resonance scan

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: The Epileptic Heart - Multiparametric Cardiac Magnetic Resonance Imaging for Detection and Quantification of Acute and Chronic Cardiac Involvement in Patients With Epilepsy
• Actual Study Start Date: Mar 7, 2021
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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].

2. 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 [%].

3. 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 [%]).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Bonn, Clinic and Polyclinic for Epileptology	Bonn	NRW	Germany	53127
2	University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology	Bonn	NRW	Germany	53127

Sponsors and Collaborators

• University Hospital, Bonn

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Julian Alexander Luetkens, Principal Investigator, Senior Physician, University Hospital, Bonn
• ClinicalTrials.gov Identifier: NCT05041296
• Other Study ID Numbers: 534/20
• First Posted: Sep 13, 2021
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Epilepsy; Cardiomyopathies

Study Results

No Results Posted as of Sep 13, 2021