primary angioplasty for acute MI within 30-60 days with at least one of the following criteria: 1) TIMI flow after PCI less than 3
Conditions
Interventions
Sponsors
A.R. Ramdat Misier, MD, PhD, Zwolle, The Netherlands
J.P. Ottervanger MD, PhD, Zwolle, The Netherlands
Prof. M.J. Schalij MD, PhD, Leiden, The Netherlands
Prof. F. Zijlstra MD, PhD, Groningen, The Netherlands
E.F.D. Wever MD, PhD, Nieuwegein, The Netherlands
M.J. de Boer, MD, PhD (Zwolle, The Netherlands)
W. Beukema, MD (Zwolle, The Netherlands)
L. van Erven, MD, PhD (Leiden, The Netherlands)
I.C. van Gelder, MD, PhD (Groningen, The Netherlands)
Eligibility
Inclusion criteria
Inclusion criteria: ST-elevation myocardial infarction treated with primary PCI within 30 days and 60 days before randomisation2.At least one of the following criteria: 1. TIMI flow after primary PCI less than 3 in the infarct related vessel; 2. Left ventricular ejection lower than 30% as measured within 4 days after admission.
Exclusion criteria
Exclusion criteria: 1. Class I indication for ICD implantation; 2. Documented previous myocardial infarction with LVEF < 30%; 3. Age < 18 years; 4. Heart failure with New York Heart Association functional class IV; 5. Inotropic medication within 2 weeks before randomisation; 6. Mechanical tricuspid valve; 7. Serious comorbidity such as cancer, with a high likelihood of death during the trial; 8. Advanced cerebrovascular disease; 9. Unwilling or unable to sign the consent form for participation; 10. Females of childbearing age not using medically prescribed contraceptives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is all-cause mortality. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are the incidence of sudden cardiac death and sustained ventricular tachycardia (VT). Sudden cardiac death is defined as occurring within 1 hour of the onset of symptoms or, if death is not witnessed, during sleep or within 24 hours of last occasion on which the patient was seen in a healthy state. | — |
Contacts
Public ContactJ. Klijn
Diagram B.V. Zwolle Dokter Stolteweg 96
Outcome results
None listed