NCT05041296

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. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 7, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 13, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

August 27, 2021

Last Update Submit

September 7, 2021

Conditions

EpilepsyCardiomyopathies

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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 Arms (3)

Chronic group

Chronic epilepsy with recurrent seizures

Diagnostic Test: Cardiac magnetic resonance scan

Acute group

Epilepsy and short-term history of seizures

Diagnostic Test: Cardiac magnetic resonance scan

Control group

Healthy participants

Diagnostic Test: Cardiac magnetic resonance scan

Interventions

Cardiac magnetic resonance scanDIAGNOSTIC_TEST

Multiparametric cardiac magnetic resonance including traditional and quantitative functional and structural parameters

Acute groupChronic groupControl group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • diagnosed epilepsy
  • examination under usual antiepileptic pharmacotherapy or medication up-dosing (if medication was reduced during video-EEG recording)
  • age between 18-60 years

You may not qualify if:

  • underlying cardiac disease, e.g. coronary artery disease, previous myocardial infarction, previous myocarditis, complex congenital heart defect, known cardiomyopathy of other cause
  • pregnant and breastfeeding women
  • patients who use IUD for contraception
  • patients with a contraindication to contrast enhanced MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Bonn, Clinic and Polyclinic for Epileptology

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology

Bonn, North Rhine-Westphalia, 53127, Germany

RECRUITING

MeSH Terms

Conditions

EpilepsyCardiomyopathies

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeart DiseasesCardiovascular Diseases

Central Study Contacts

Julian A. Luetkens, PD Dr.

CONTACT

+49 228 287 19860julian.luetkens@ukbonn.de

Alexander Isaak, Dr.

CONTACT

+49 228 287 15960alexander.isaak@ukbonn.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Senior Physician

Study Record Dates

First Submitted

August 27, 2021

First Posted

September 13, 2021

Study Start

March 7, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

September 13, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)