Myocardial Infarction
Conditions
Keywords
Myocardial infarction, Risk stratification, Sudden cardiac death, Preserved ejection fraction, Programmed ventricular stimulation
Brief summary
The purpose of the study is to assess the prevalence and the prognostic value of non-invasive indexes and programmed ventricular stimulation for sudden cardiac death in post-myocardial infarction (MI) patients with left ventricular ejection fraction (LVEF)\>40%.
Detailed description
1000 asymptomatic post-MI patients\>40%, at least 40 days post-MI, revascularized or without needing further revascularization (in any case without any evidence of ischemia) will be enrolled. The patients will be divided into two categories: 1. Asymptomatic patients with revascularized ST-elevation MI (STEMI) (remaining stenoses in non culprit vessels \<70%) at 40 days post-MI (when LVEF\>40% will be re-assessed) 2. Asymptomatic patients late (at any time after 40 days) after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF\>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization All patients will undergo non-invasive evaluation (ECG, Holter monitoring and 45-min high resolution recording). In case they fulfill at least one out of seven pre-specified criteria they will undergo programmed ventricular stimulation and implantable cardioverter-defibrillator (ICD) implantation (if inducible) All patients will be followed-up for 3 years for sudden cardiac death and its surrogate (appropriate ICD activation)
Interventions
PROCEDUREProgrammed ventricular stimulation
Programmed ventricular stimulation in high-risk patients based on non-invasive evaluation
DEVICEICD implantation
ICD implantation in patients with induced VT in programmed ventricular stimulation
Sponsors
Medtronic
General Electric
University of Athens
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Asymptomatic patients with revascularized STEMI (remaining stenoses in non culprit vessels \<70%) at 40 days post-MI (when LVEF\>40% will be re-assessed) * Asymptomatic patients late after MI (initially STEMI-NSTEMI at discharge Q-non Q) with LVEF\>40% right after a negative stress test or right after a negative for stenoses control coronary catheterization
Exclusion criteria
* Episodes of sustained VT or aborted sudden cardiac death (SCD) 48 hours after the acute MI phase. * Episodes of syncope within the last 6 months * Cancer, liver failure (cirrhosis), end-stage renal disease * Use of anti-arrhythmic drugs other than b-blockers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation | From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup | The number of patients from each risk level group meeting the primary endpoint will be used to assess diagnostic accuracy (positive/negative predictive value, sensitivity and specificity) of the proposed two-stage, PVS-inclusive, risk stratification approach for the allocation of an ICD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Mortality | From completion of risk stratification to study completion or outcome occurrence (mean 32 months) | All-cause mortality |
Countries
Greece
Participant flow
Recruitment details
From April 2014 to July 2018, 575 consecutive patients were enrolled in the seven Departments of Cardiology participating in the study
Participants by arm
| Arm | Count |
|---|---|
| Low Risk Group No NIRFs present - no invasive PVS performed | 371 |
| Intermediate Risk Group At least one NIRF present - noninducible upon PVS | 111 |
| High Risk Group At least one NIRF present AND inducible upon PVS | 41 |
| Total | 523 |
Baseline characteristics
| Characteristic | Intermediate Risk Group | High Risk Group | Total | Low Risk Group |
|---|---|---|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 10.9 | 61.7 years STANDARD_DEVIATION 9.2 | 57 years STANDARD_DEVIATION 10.4 | 55.7 years STANDARD_DEVIATION 10.2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment Greece | 111 participants | 41 participants | 523 participants | 371 participants |
| Sex: Female, Male Female | 15 Participants | 1 Participants | 73 Participants | 57 Participants |
| Sex: Female, Male Male | 96 Participants | 40 Participants | 450 Participants | 314 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 371 | 4 / 111 | 1 / 41 |
| other Total, other adverse events | 0 / 371 | 0 / 111 | 0 / 41 |
| serious Total, serious adverse events | 0 / 371 | 0 / 111 | 0 / 41 |
Outcome results
Primary
Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation
The number of patients from each risk level group meeting the primary endpoint will be used to assess diagnostic accuracy (positive/negative predictive value, sensitivity and specificity) of the proposed two-stage, PVS-inclusive, risk stratification approach for the allocation of an ICD
Time frame: From stratification completion (i.e. allocation to one of three risk level groups) until either occurrence of primary endpoint or study completion (mean 32months) - study stopped early due to emergence of clearly defined high risk subgroup
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Risk Group | Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation | 0 participants |
| Intermediate Risk Group | Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation | 0 participants |
| High Risk Group | Number of Participants With Major Arrhythmic Events (MAEs) - Present When One of the Following Occurred: Sudden Cardiac Death, Sustained Ventricular Tachycardia, or Implantable Cardioverter - Defibrillator (ICD) Activation | 9 participants |
Secondary
Total Mortality
All-cause mortality
Time frame: From completion of risk stratification to study completion or outcome occurrence (mean 32 months)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Risk Group | Total Mortality | 0 Participants |
| Intermediate Risk Group | Total Mortality | 4 Participants |
| High Risk Group | Total Mortality | 1 Participants |