Sudden Cardiac Death Stratification in Myotonic Dystrophy Type 1 Patients
NCT ID: NCT03784586
Last Updated: 2021-06-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
70 participants
OBSERVATIONAL
2012-02-01
2023-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
RAMYD Study - Evaluation of Arrhythmic Risk in Myotonic Dystrophy
NCT00127582
Sleep Breathing Disorders, a Main Trigger for Cardiac ARythmias in Type I Myotonic Dystrophy ?
NCT02375087
Diastolic Function in Myotonic Dystrophy Type 1
NCT06029192
Cardiac Arrhythmias and Sudden Death in Patients Affected With Laminopathies
NCT02601066
RandomIsed sTudy of Physiologic cArdiac stimuLation in patIents With Atrio-ventricular Conduction Disease
NCT07279870
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a double-arm prospective observational study.
Patient population:
To be included in the study, DM1 patients had to have at least 18 years old, LVEF \>35% on two-dimensional echocardiography, permanent pacing indication after non-invasive electrocardiographic evaluation or invasive EPS evaluation, according to the current guidelines. The following exclusion criteria were applied: electrolyte imbalance, thyroid disorders, prior cardiac surgery, prior cardiac arrest, prior spontaneous sustained ventricular arrhythmias, absuntion of antiarrhythmic drugs or medication known to affect cardiac conduction. All eligible DM1 patients underwent EPS for programmed ventricular stimulation; those in whom a sustained ventricula arrhythmia was inducible underwent subsequently ICD implantation. Non-inducible DM1 patients did not receive an ICD and underwent pacemaker implantation.
Endpoints:
The primary endpoint was all-cause mortality. Secondary end-points were sudden death (SD), death due to cardiac arrhythmias, ICD interventions and arrhythmic events in implanted patients.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Positive EPS - ICD
Patients with inducible sustained ventricular tachycardia or ventricular fibrillation at EPS evaluation underwent ICD implantation
No interventions assigned to this group
Negative EPS - PMK
All non inducible patients underwent PMK implantation
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* LVEF \>35% on two-dimensional echocardiography
* Permanent pacing indication according to the current guidelines
Exclusion Criteria
* Thyroid disorders
* Prior cardiac surgery
* Prior cardiac arrest
* Prior spontaneous sustained ventricular arrhythmias
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Campania Luigi Vanvitelli
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vincenzo Russo
MD, PhD, Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Vincenzo Russo
Naples, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
01_MD1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.