N/A
N=312
CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction
Acute Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00145119 ↗Enrolled (actual)
312
Serious AEs
12.2%
Results posted
Jan 2014
Primary outcome: Primary: ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) — 25; 8; 3; 2 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) |
25; 8; 3; 2; 12 | — |
Summary
The purpose of this study is to assess the incidence of tachy- and bradyarrhythmic episodes in patients with acute myocardial infarction with depressed ventricular function and to determine the predictive value of several invasive and non-invasive risk markers for life-threatening arrhythmia
Eligibility Criteria
Inclusion Criteria
- Acute myocardial infarction (< 21 days)
- Ejection fraction <= 40 % or wall motion index <= 1.3
Exclusion Criteria
- Implantable loop recorder can't be implanted within 3 weeks after MI
- NYHA class IV
- Planned or previous ICD implantation
- Planned CABG
- Severe valvular disease
- Pregnancy
- Life expectancy < 1 year for non-cardiac cause
Data sourced from ClinicalTrials.gov (NCT00145119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.