NCT02419833

Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients

Randomized Study of ImmeDiate Versus DeLayEd Invasive Intervention in Patients With Non ST-segment Elevation Myocardial Infarction

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 323 (actual)
• Sponsor: Clinical Centre of Serbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Myocardial Infarction

Interventions

Type	Name	Description
PROCEDURE	Immediate invasive intervention	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
PROCEDURE	Delayed invasive intervention	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
DEVICE	Coronary artery stenting	Implantation of coronary stents

Timeline

• Start date: 2009-09-01
• Primary completion: 2013-03-01
• Completion: 2018-03-01
• First posted: 2015-04-17
• Last updated: 2020-07-13

Locations

1 site across 1 country: Serbia