Non-ischemic CardiomyopathyNCT04607265
Sudden Death Stratification
An observational study of Non-ischemic Cardiomyopathy, run by Hospices Civils de Lyon.
Trial summary
Sudden cardiac death (SCD) risk stratification is a challenge in non-ischemic cardiomyopathy (NICM). The underlying mechanism of monomorphic ventricular tachycardia (VT) is mostly scar related. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-ischemic Cardiomyopathy
- What is being tested?
- Cardiac MRI
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 Dec 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that underwent VT ablation, had a cardiac MRI prior to the ablation and suffered from non-ischemic cardiomyopathy (NICM) were included in the VT group. A 2:1 ratio of patients with non-ischemic cardiomyopathy and no history of ventricular tachycardia were included in the control group.
Who may be able to join
- Adult with NICM
- Previous history of ventricular tachycardia (VT) and no previous history of VT
Who cannot join
- Inherited cardiomyopathies
- Previous history of myocarditis WITHOUT oedema/scar at the MRI
About this study
Official title: Channel Detection to Predict Ventricular Arrhythmia in Patients With Non-ischemic Cardiomyopathy
Sudden cardiac death (SCD) risk stratification is a challenge in non-ischemic cardiomyopathy (NICM). The underlying mechanism of monomorphic ventricular tachycardia (VT) is mostly scar related. While electrophysiological mechanisms underlying ventricular arrhythmia are well known, late gadolinium enhanced (LGE) cardiac MRI-3D reconstructions are now able to guide VT ablation procedures. Such exam may help in identifying specific properties of scar at risk of malignant arrhythmia.
- Conditions
- Non-ischemic Cardiomyopathy
- Being tested
- Cardiac MRI
- Keywords
- LGE MRI, Ventricular tachycardia, sudden cardiac death, non-ischemic cardiomyopathy
- Medical subject headings
- Tachycardia, Ventricular, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic test
Comparison of scar characteristics on cardiac MRI between the two groups.
| Study group | Role | What they receive |
|---|---|---|
| Ventricular tachycardia (VT) group | NICM patients admitted for a VT ablation with a pre-operative cardiac- MRI. Receives: Diagnostic Test: Cardiac MRI | |
| Control group | NICM patients without ventricular arrhythmia and a previous cardiac-MRI. The matching with the VT group was based on the age of the patients, the mean LVEF, the time between the initial diagnosis and the MRI examination, and the origin of the NICM. Receives: Diagnostic Test: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect pro arrhythmogenic scar characteristics
The outcomes will aim to provide scar characteristics from 3D cardiac MRI reconstructions to detect pro arrhythmic properties in NICM patients. Comparisons between NICM patients who experienced VT ablation and NICM patients without history of ventricular arrhythmia will be made.
In both groups, Primary outcome will aim to measure the number of the conducting channels into scars (n).
Measured: baseline : collected at the time of the cardiac MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Jan 2017
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607265
- Sponsor's protocol ID
- 69HCL20_0838
- Status last verified
- Sep 2020
- First submitted
- 28 Sep 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Channel Detection to Predict Ventricular Arrhythmia in Patients With Non-ischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT04607265
- Acronym / sponsor ID
- 69HCL20_0838
- Conditions
- Non-ischemic Cardiomyopathy
- Keywords
- LGE MRI, Ventricular tachycardia, sudden cardiac death, non-ischemic cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 29 Oct 2020 (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.
Sudden cardiac death (SCD) risk stratification is a challenge in non-ischemic cardiomyopathy (NICM). The underlying mechanism of monomorphic ventricular tachycardia (VT) is mostly scar related. While electrophysiological mechanisms underlying ventricular arrhythmia are well known, late gadolinium enhanced (LGE) cardiac MRI-3D reconstructions are now able to guide VT ablation procedures. Such exam may help in identifying specific properties of scar at risk of malignant arrhythmia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventricular tachycardia (VT) group | – | Diagnostic Test: Cardiac MRINICM patients admitted for a VT ablation with a pre-operative cardiac- MRI. |
| Control group | – | Diagnostic Test: Cardiac MRINICM patients without ventricular arrhythmia and a previous cardiac-MRI. The matching with the VT group was based on the age of the patients, the mean LVEF, the time between the initial diagnosis and the MRI examination, and the origin of the NICM. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that underwent VT ablation, had a cardiac MRI prior to the ablation and suffered from non-ischemic cardiomyopathy (NICM) were included in the VT group. A 2:1 ratio of patients with non-ischemic cardiomyopathy and no history of ventricular tachycardia were included in the control group.
Key inclusion criteria (2 listed)
- Adult with NICM
- Previous history of ventricular tachycardia (VT) and no previous history of VT
Key exclusion criteria (2 listed)
- Inherited cardiomyopathies
- Previous history of myocarditis WITHOUT oedema/scar at the 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 MRIComparison of scar characteristics on cardiac MRI between the two groups. | Diagnostic test | Control group, Ventricular tachycardia (VT) group |
Primary outcome
Detect pro arrhythmogenic scar characteristics
Time frame: baseline : collected at the time of the cardiac MRI
The outcomes will aim to provide scar characteristics from 3D cardiac MRI reconstructions to detect pro arrhythmic properties in NICM patients. Comparisons between NICM patients who experienced VT ablation and NICM patients without history of ventricular arrhythmia will be made. In both groups, Primary outcome will aim to measure the number of the conducting channels into scars (n).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-ischemic Cardiomyopathy, run by Hospices Civils de Lyon.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect pro arrhythmogenic scar characteristics (time frame: baseline : collected at the time of the cardiac MRI). 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 29 Oct 2020.