Acute Myocardial Infarction
Conditions
Keywords
Acute myocardial infarction, Cardiac arrhythmias, Left ventricular dysfunction, Implantable loop recorder, Risk stratifiers
Brief 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
Interventions
None listed
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) | 2 year | ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT) |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction | 312 |
| Total | 312 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 45 |
Baseline characteristics
| Characteristic | Patients |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 11 |
| Diabetes | 62 participants |
| Ejection fraction index < 7 days after index MI | 31 percent STANDARD_DEVIATION 6 |
| Pior MI | 116 participants |
| Sex: Female, Male Female | 73 Participants |
| Sex: Female, Male Male | 239 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 38 / 312 |
Outcome results
Primary
ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT)
ECG-documented ventricular fibrillation or symptomatic sustained ventricular tachycardia (VT)
Time frame: 2 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Patients | ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) | Primary endoints | 25 participants |
| Patients | ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) | Sudden death | 8 participants |
| Patients | ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) | Resuscitated cardiac arrest | 3 participants |
| Patients | ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) | Syncope | 2 participants |
| Patients | ECG-documented Ventricular Fibrillation or Symptomatic Sustained Ventricular Tachycardia (VT) | Symptomatic sustained VT | 12 participants |