EpilepsyNCT05041296
Cardiac MRI for Detection of Acute and Chronic Cardiac Involvement in Patients With Epilepsy
An observational study of Epilepsy and Cardiomyopathies, run by University Hospital, Bonn at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epilepsy, Cardiomyopathies
- What is being tested?
- Cardiac magnetic resonance scan
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- 7 Mar 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Adult
Study population: Patients with epilepsy with treatment in the Clinic and Polyclinic for Epileptology of the University Hospital Bonn (Primary care clinic)
Who may be able to join
- diagnosed epilepsy
- examination under usual antiepileptic pharmacotherapy or medication up-dosing (if medication was reduced during video-EEG recording)
- age between 18-60 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Bonn, Clinic and Polyclinic for Epileptology
Bonn, North Rhine-Westphalia, 53127
Rainer Surges, Prof., +49 228 287 15727, rainer.surges@ukbonn.de
- Recruiting
University Hospital Bonn, Clinic for Diagnostic and Interventional Radiology
Bonn, North Rhine-Westphalia, 53127
Julian A Luetkens, PD Dr., julian.luetkens@ukbonn.de
Alexander Isaak, Dr., alexander.isaak@ukbonn.de
About this study
Official title: 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:
- 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.
- 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.
- Conditions
- Epilepsy, Cardiomyopathies
- Being tested
- Cardiac magnetic resonance scan
- Medical subject headings
- Epilepsy, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac magnetic resonance scanDiagnostic test
Multiparametric cardiac magnetic resonance including traditional and quantitative functional and structural parameters
| Study group | Role | What they receive |
|---|---|---|
| Chronic group | Chronic epilepsy with recurrent seizures Receives: Diagnostic Test: Cardiac magnetic resonance scan | |
| Acute group | Epilepsy and short-term history of seizures Receives: Diagnostic Test: Cardiac magnetic resonance scan | |
| Control group | Healthy participants Receives: Diagnostic Test: Cardiac magnetic resonance scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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].
Measured: Measurement will be performed within 2 weeks after MRI scan.
Secondary outcomes (3)
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].
Measured: 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 [%].
Measured: 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 [%]).
Measured: Measurement will be performed within 2 weeks after MRI scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start7 Mar 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julian Alexander Luetkens, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041296
- Sponsor's protocol ID
- 534/20
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epileptic Heart - Multiparametric Cardiac Magnetic Resonance Imaging for Detection and Quantification of Acute and Chronic Cardiac Involvement in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT05041296
- Acronym / sponsor ID
- 534/20
- Conditions
- Epilepsy, Cardiomyopathies
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- 7 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic group | – | Diagnostic Test: Cardiac magnetic resonance scanChronic epilepsy with recurrent seizures |
| Acute group | – | Diagnostic Test: Cardiac magnetic resonance scanEpilepsy and short-term history of seizures |
| Control group | – | Diagnostic Test: Cardiac magnetic resonance scanHealthy participants |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with epilepsy with treatment in the Clinic and Polyclinic for Epileptology of the University Hospital Bonn (Primary care clinic)
Key inclusion criteria (3 listed)
- diagnosed epilepsy
- examination under usual antiepileptic pharmacotherapy or medication up-dosing (if medication was reduced during video-EEG recording)
- age between 18-60 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac magnetic resonance scanMultiparametric cardiac magnetic resonance including traditional and quantitative functional and structural parameters | Diagnostic test | Acute group, Chronic group, Control group |
Primary outcome
T1 relaxation time
Time frame: 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].
3 secondary outcomes
T2 relaxation time
Time frame: Measurement will be performed within 2 weeks after MRI scan.
Extracellular volume fraction
Time frame: Measurement will be performed within 2 weeks after MRI scan.
Myocardial strain
Time frame: Measurement will be performed within 2 weeks after MRI scan.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Epilepsy
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Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Cardiomyopathies, run by University Hospital, Bonn at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julian A. Luetkens, PD Dr. (+49 228 287 19860, julian.luetkens@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T1 relaxation time (time frame: Measurement will be performed within 2 weeks after MRI scan.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.