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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05041296
Enrollment
200
Registered
2021-09-13
Start date
2021-03-07
Completion date
2024-12-31
Last updated
2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Cardiomyopathies

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.

Interventions

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

Sponsors

University Hospital, Bonn
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years

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

Design outcomes

Primary

MeasureTime frameDescription
T1 relaxation timeMeasurement 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

MeasureTime frameDescription
T2 relaxation timeMeasurement 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 \[ms\].
Extracellular volume fractionMeasurement 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 \[%\].
Myocardial strainMeasurement 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 \[%\]).

Countries

Germany

Contacts

Primary ContactJulian A. Luetkens, PD Dr.
julian.luetkens@ukbonn.de+49 228 287 19860
Backup ContactAlexander Isaak, Dr.
alexander.isaak@ukbonn.de+49 228 287 15960

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026