Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients

NCT ID: NCT02419833

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 323 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2018-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Immediate invasive intervention

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

Group Type: EXPERIMENTAL

Immediate invasive intervention

Intervention Type: 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

Coronary artery stenting

Intervention Type: DEVICE

Implantation of coronary stents

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 within 2-72 hours of admission

Group Type: ACTIVE_COMPARATOR

Delayed invasive intervention

Intervention Type: 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

Intervention Type: DEVICE

Implantation of coronary stents

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Coronary artery stenting

Implantation of coronary stents

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. episode of chest pain occurring no longer than 24 hours prior to admission

2. elevation of cardiac troponin I above the upper limit of normal (ULN)

3. new ST-segment depression at least 1 millivolt (mV) and/or T-wave inversion or transient ST-segment elevation in ≥ 2 contiguous leads

Exclusion Criteria

1. age < 18 years

2. persistent ST-segment elevation

3. hemodynamic instability

4. cardiogenic shock on admission

5. life-threatening ventricular arrhythmias on admission

6. refractory angina on admission

7. active bleeding

8. any contraindication for the use of dual antiplatelet therapy (DAPT)

9. presence of comorbidities with life expectancy < 6 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Centre of Serbia

OTHER

Sponsor Role: lead

Responsible Party

Aleksandra Milosevic

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Goran Stankovic, MD, PhD

Role: STUDY_DIRECTOR

Clinical Centre of Serbia

Aleksandra Milosevic, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Centre of Serbia

Zorana Vasiljevic, MD, PhD

Role: STUDY_CHAIR

Clinical Centre of Serbia

Locations

Clinical Centre of Serbia, Department of Cardiology

Belgrade, , Serbia

Countries

Serbia

References

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.

Reference Type: DERIVED

PMID: 26777321 (View on PubMed)

Other Identifiers

440/VII/1

Identifier Type: -

Identifier Source: org_study_id