Ischemic Heart Disease, ST-segment Elevation Myocardial Infarction
Conditions
Keywords
Myocardial infarction, Late presenters, Primary percutaneous coronary intervention, Reperfusion, Angioplasty, Duration of ischemia, Cardiovascular magnetic resonance imaging
Brief summary
Although recommended therapy for patients with ST-segment elevation myocardial infarction is primary PCI, it remains unestablished whether patients with a symptom duration of more 12 hours benefit from acute revascularisation. This study aims to investigate whether acute intervention is superior to subacute intervention in these patients.
Detailed description
The recommended therapy for patients with ST-segment elevation myocardial infarction (STEMI) is to restore normal coronary blood flow with timely reperfusion by percutaneous coronary intervention (PCI), and thereby minimize the extent of cell death and preserving cardiac function. The duration of ischemia and timely PCI are major determinants for the size of the myocardial infarction and prognosis. Thus, acute PCI should be performed within 12 hours after symptom onset. The effect of PCI and timing of PCI are, however, much more uncertain for late presenters who contact the health service \> 12 hours from symptom. Thus, it is still unknown whether late presenters should be treated with acute PCI or medical treatment with delayed PCI (24-72 h after first medical contact). The study investigates the effect on final salvage index evaluated by magnetic resonance imaging of acute PCI of late presenters. The overall objective of the study is to investigate whether late presenters may benefit from acute PCI, and thus whether to extend the currently recommended time limit of 12 hours for acute PCI in patients with STEMI.
Interventions
PROCEDUREPCI
Guideline directed Percutaneous Coronary Intervention
Sponsors
Thomas Engstrom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria: * Patients more than 18 years of age. * STEMI \> 12 hours and \< 36 hours. * Clinical stable, i.e. no on going angina, hemodynamically stable (systolic BP \> 90) and Killip class \< 3.
Exclusion criteria
* Clinical instability which requires an acute invasive strategy. * Left main occlusion or multivessel disease which requires CABG. * Previous Q-wave infarction in the current infarct related artery. * Left Bundle Branch Block (LBBB). * Severe renal insufficiency. * Pacemaker * Chronic atrial fibrillation. * Previous Coronary Artery Bypass Surgery (CABG). * Pregnancy. * Other severe illness with life expectancy less than 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute salvage index evaluated by MRI | 1-2 days | MRI within 48 timer after index admission will be used to measure are at risk (AAR, T2-weighted) and acute infarct size (IZ). Acute salvage index is (AAR-IZ)/AAR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Final infarct size | 3 months | Please see above |
| Final myocardial salvage index | 1-2 days | As for primary endpoint but IZ is measured within the index admission |
| Acute infarct size | 1-2 days | — |
| Microvascular obstruction (MVO) | 1-2 days | — |
| Left Ventricular Ejection Fraction (LVEF) | 1-2 days and 3 months | Measured by MRI |
| All-cause mortality | Until last included patient has been followed for 180 days | Mortality due to any cause |
| All-cause mortality and hospitalization for heart failure | Until last included patient has been followed for 180 days | — |
| All-cause mortality, hospitalization for heart failure and malignant arrhythmia | Until last included patient has been followed for 180 days | — |
| Cardiac death | Until last included patient has been followed for 180 days | Death caused by a malfunction of the heart muscle or electrical system. |
| Hospitalization for heart failure | Until last included patient has been followed for 180 days | — |
| Spontaneous myocardial infarction | Until last included patient has been followed for 180 days | — |
| Malignant arrhythmia | Until last included patient has been followed for 180 days | VF/VT or ICD activation |
| Unplanned revascularization | Until last included patient has been followed for 180 days | Any unplanned revascularization |
| Stroke | Until last included patient has been followed for 180 days | Any stroke or TIA |
Countries
Denmark
Contacts
PRINCIPAL_INVESTIGATORLars Nepper-Christensen, MD
Rigshospitalet, Denmark
Outcome results
None listed