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RAMYD Study - Evaluation of Arrhythmic Risk in Myotonic Dystrophy

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Phase: Phase 3 to Not applicable Primary endpoints: 5 to 2 · Trial status: Recruiting to Completed · Primary completion date: Dec 2009 · 6 morev4 Show all 10 changesShow less
    • Primary endpoints: 5 to 2
    • Trial status: Recruiting to Completed
    • Primary completion date: Dec 2009
    • Completion date: Dec 2010
    • Interventions: Electrophysiological study (Procedure), pacemaker (PM) implant, internal cardiac defibrillator (ICD) implant, loop-recorder implant (Device) to Electrophysiological study (Procedure), pacemaker , implantable cardiac defibrillator or loop-recorder implant (Device)
    • Secondary endpoints shortened, about 32 words
    • Site details revised
    • Study arms: 0 to 1
    • Collaborators shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  2. Minor Study Status, Study Descriptionv3
  3. Notable Primary endpoints: 2 to 5 Interventions: Electrophysiological study (Procedure), PM implant, ICD implant, loop-recorder implant (Device) to Electrophysiological study (Procedure), pacemaker (PM) implant, internal cardiac defibrillator (ICD) implant, loop-recorder implant (Device) · Secondary endpoints: 1 to 4 · Study title expanded, about 8 words · 1 morev2 Show all 5 changesShow less
    • Interventions: Electrophysiological study (Procedure), PM implant, ICD implant, loop-recorder implant (Device) to Electrophysiological study (Procedure), pacemaker (PM) implant, internal cardiac defibrillator (ICD) implant, loop-recorder implant (Device)
    • Secondary endpoints: 1 to 4
    • Study title expanded, about 8 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a prospective multicentric Italian study to evaluate the arrhythmic risk in myotonic dystrophy type 1.
Trial Details
NCT Number NCT00127582
Lead Sponsor Catholic University of the Sacred Heart
Conditions Myotonic Dystrophy, Sudden Cardiac Death
Enrollment 537 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov