Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients

NCT02419833 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 323

Last updated 2020-07-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Clinical Centre of Serbia

    lead OTHER

Principal Investigators

  • Goran Stankovic, MD, PhD · Clinical Centre of Serbia

  • Aleksandra Milosevic, MD · Clinical Centre of Serbia

  • Zorana Vasiljevic, MD, PhD · Clinical Centre of Serbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-03-31
Completion
2018-03-31

Countries

  • Serbia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02419833 on ClinicalTrials.gov