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In patients with acute myocardial infarction without ST-segment elevation on ECG (non-STEMI), previous studies have indicated that routine invasive treatment confers more benefit as compared to selective invasive approach. The benefits of routine invasive coronary intervention have been the most evident in patients with higher baseline risk profile. However, the question of optimal timing of routine invasive intervention remains unsolved.
Immediate invasive intervention early after admission for non-STEMI may limit myocardial necrosis by securing the patency of the culprit coronary artery. Nevertheless, several previous studies reported higher levels of biomarkers of myocardial injury in patients undergoing early PCI. The question of earlier versus delayed procedure in non-STEMI patients may thus amount to whether the risk of intervening on an unstable plaque is greater than the risk of new ischemic events while waiting for the invasive procedure.
The purpose of the present study is to compare effects of immediate coronary intervention, within 2 hours of admission, versus delayed intervention, within 2-72 hours after admission, in patients witn non-STEMI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate invasive intervention | Experimental | Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery as soon as possible and/or within 2 hours of admission |
|
| Delayed invasive intervention | Active Comparator | Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery during the hospitalization and within 2-72 hours of admission |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate invasive intervention | Procedure | Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery as soon as possible and/or within 2 hours of admission |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause death or myocardial reinfarction | within 30 days of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of all-cause death, myocardial reinfarction or recurrent ischemia | within 30 days of randomization | |
| All-cause mortality | within 30 days, 1, 3 and 5 years after randomization | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Goran Stankovic, MD, PhD | Clinical Centre of Serbia | Study Director |
| Aleksandra Milosevic, MD | Clinical Centre of Serbia | Principal Investigator |
| Zorana Vasiljevic, MD, PhD | Clinical Centre of Serbia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Centre of Serbia, Department of Cardiology | Belgrade | 11000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26777321 | Derived | Milosevic A, Vasiljevic-Pokrajcic Z, Milasinovic D, Marinkovic J, Vukcevic V, Stefanovic B, Asanin M, Dikic M, Stankovic S, Stankovic G. Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients: The RIDDLE-NSTEMI Study. JACC Cardiovasc Interv. 2016 Mar 28;9(6):541-9. doi: 10.1016/j.jcin.2015.11.018. Epub 2016 Jan 6. |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| Delayed invasive intervention | Procedure | Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery during the hospitalization and/or within 2-72 hours of admission |
|
| Coronary artery stenting | Device | Implantation of coronary stents |
|
| Myocardial reinfarction |
| within 30 days, 1, 3 and 5 years after randomization |
| Stroke | within 30 days, 1, 3 and 5 years after randomization |
| Recurrent ischemia | within 30 days of randomization |
| Major bleeding | within 30 days, 1, 3 and 5 years after randomization |
| Duration of index hospitalization | at 30-day follow-up, the duration of hospital stay is assessed |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |