Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients (RIDDLE-NSTEMI)

July 10, 2020 updated by: Aleksandra Milosevic, Clinical Centre of Serbia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

323

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Centre of Serbia, Department of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Device: Coronary artery stenting
Implantation of coronary stents
Active Comparator: 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
Device: Coronary artery stenting
Implantation of coronary stents
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of all-cause death or myocardial reinfarction
Time Frame: within 30 days of randomization
within 30 days of randomization

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Centre of Serbia

Investigators

  • Study Director: Goran Stankovic, MD, PhD, Clinical Centre of Serbia
  • Principal Investigator: Aleksandra Milosevic, MD, Clinical Centre of Serbia
  • Study Chair: Zorana Vasiljevic, MD, PhD, Clinical Centre of Serbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

April 14, 2015

First Posted (Estimate)

April 17, 2015

Study Record Updates

Last Update Posted (Actual)

July 13, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 440/VII/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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