Sudden Cardiac Death Stratification in Myotonic Dystrophy Type 1 Patients (ACADEMY 1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03784586|
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : September 19, 2019
|Condition or disease|
|Myotonic Dystrophy 1 Sudden Cardiac Death|
This is a double-arm prospective observational study.
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||51 participants|
|Official Title:||The Electrophysiological Study Guided ICD Strategy in Prevention of Arrhythmic Cardiac Death in Myotonic Dystrophy Type 1 Patients With Conduction System Disease (ACADEMY 1 Study)|
|Actual Study Start Date :||February 1, 2012|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2020|
Positive EPS - ICD
Patients with inducible sustained ventricular tachycardia or ventricular fibrillation at EPS evaluation underwent ICD implantation
Negative EPS - PMK
All non inducible patients underwent PMK implantation
- All-cause mortality [ Time Frame: 24 months ]
- Sudden cardiac death [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03784586
|Contact: Vincenzo Russo, MD,PhDemail@example.com|
|Contact: Andrea Antonio Papa, MDfirstname.lastname@example.org|
|Naples, Italy, 80136|