Sudden Cardiac Death Stratification in Myotonic Dystrophy Type 1 Patients
ACADEMY 1
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)
1 other identifier
observational
70
1 country
1
Brief Summary
The aim of the study is to evaluate if the electrophysiological study (EPS) guided therapy, including the prophylactic implantation of implantable cardioverter defibrillator (ICD), in inducible patients, is able to improve survival in comparison with conventional therapy (CONV strategy) in Myotonic Dystrophy type 1 patients with conduction disorders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 17, 2018
CompletedFirst Posted
Study publicly available on registry
December 24, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedJune 18, 2021
June 1, 2021
10.4 years
December 17, 2018
June 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sudden Cardiac Death
24 months
Secondary Outcomes (1)
All-cause mortality
24 months
Study Arms (2)
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
Eligibility Criteria
MD1 patients with permanent pacing indication and needed of sudden cardiac death screening.
You may qualify if:
- MD1 diagnosis genetically confirmed
- LVEF \>35% on two-dimensional echocardiography
- Permanent pacing indication according to the current guidelines
You may not qualify if:
- Electrolyte imbalance
- Thyroid disorders
- Prior cardiac surgery
- Prior cardiac arrest
- Prior spontaneous sustained ventricular arrhythmias
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vincenzo Russo
Naples, 80136, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Assistant Professor
Study Record Dates
First Submitted
December 17, 2018
First Posted
December 24, 2018
Study Start
February 1, 2012
Primary Completion
June 30, 2022
Study Completion
May 31, 2023
Last Updated
June 18, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share