Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients

Myocardial Infarction Clinical Trial

— RIDDLE-NSTEMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02419833
• Other study ID #: 440/VII/1
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: March 2018

Study information

• Verified date: July 2020
• Source: Clinical Centre of Serbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: March 2018
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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
• 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

Locations

Country	Name	City	State
Serbia	Clinical Centre of Serbia, Department of Cardiology	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Centre of Serbia

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of all-cause death or myocardial reinfarction		within 30 days of randomization
Secondary	Composite of all-cause death, myocardial reinfarction or recurrent ischemia		within 30 days of randomization
Secondary	All-cause mortality		within 30 days, 1, 3 and 5 years after randomization
Secondary	Myocardial reinfarction		within 30 days, 1, 3 and 5 years after randomization
Secondary	Stroke		within 30 days, 1, 3 and 5 years after randomization
Secondary	Recurrent ischemia		within 30 days of randomization
Secondary	Major bleeding		within 30 days, 1, 3 and 5 years after randomization
Secondary	Duration of index hospitalization		at 30-day follow-up, the duration of hospital stay is assessed