Trial Outcomes & Findings for CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction (NCT NCT00145119)

NCT ID: NCT00145119

Last Updated: 2025-07-02

Results Overview

ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)

• Recruitment status: COMPLETED
• Target enrollment: 312 participants
• Primary outcome timeframe: 2 year
• Results posted on: 2025-07-02

Participant Flow

Participant milestones

Measure	Patients
Overall Study STARTED	312
Overall Study COMPLETED	267
Overall Study NOT COMPLETED	45

Reasons for withdrawal

Measure	Patients
Overall Study Death	45

Baseline Characteristics

CARISMA : Cardiac Arrhythmias and Risk Stratification After MyoCardial Infarction

Baseline characteristics by cohort

Measure	Patients n=312 Participants Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
Age, Continuous	65 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	73 Participants n=5 Participants
Sex: Female, Male Male	239 Participants n=5 Participants
Diabetes	62 participants n=5 Participants
Ejection fraction index < 7 days after index MI	31 percent STANDARD_DEVIATION 6 • n=5 Participants
Pior MI	116 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 year

ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)

Outcome measures

Measure	Patients n=312 Participants Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) Sudden death	8 participants
ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) Primary endoints	25 participants
ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) Resuscitated cardiac arrest	3 participants
ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) Syncope	2 participants
ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) Symptomatic sustained VT	12 participants

Adverse Events

Patients

Serious events: 38 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patients n=312 participants at risk Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction.
Cardiac disorders Death	12.2% 38/312 • Number of events 38 • Other (non-serious) adverse events were not collected/ assessed Other (non-serious) adverse events were not collected/ assessed

Other adverse events

Adverse event data not reported

Additional Information

Director CRDM

Medtronic Bakken Research Center

Phone: +31 43 3566

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place