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

NCT ID: NCT05041296

Last Updated: 2021-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-07

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy Cardiomyopathies

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic group

Chronic epilepsy with recurrent seizures

Cardiac magnetic resonance scan

Intervention Type DIAGNOSTIC_TEST

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

Acute group

Epilepsy and short-term history of seizures

Cardiac magnetic resonance scan

Intervention Type DIAGNOSTIC_TEST

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

Control group

Healthy participants

Cardiac magnetic resonance scan

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Cardiac magnetic resonance scan

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Julian Alexander Luetkens

Principal Investigator, Senior Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Bonn, Clinic and Polyclinic for Epileptology

Bonn, North Rhine-Westphalia, Germany

Site Status RECRUITING

University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology

Bonn, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Julian A. Luetkens, PD Dr.

Role: CONTACT

+49 228 287 19860

Alexander Isaak, Dr.

Role: CONTACT

+49 228 287 15960

Facility Contacts

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Rainer Surges, Prof.

Role: primary

+49 228 287 15727

Julian A Luetkens, PD Dr.

Role: primary

Alexander Isaak, Dr.

Role: backup

Other Identifiers

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534/20

Identifier Type: -

Identifier Source: org_study_id

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