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

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Immediate invasive intervention
Delayed invasive intervention
Coronary artery stenting
Sponsored by
Clinical Centre of Serbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring non-STEMI, immediate, delayed, PCI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Centre of Serbia, Department of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate invasive intervention

Delayed invasive intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

Composite of all-cause death or myocardial reinfarction

Secondary Outcome Measures

Composite of all-cause death, myocardial reinfarction or recurrent ischemia
All-cause mortality
Myocardial reinfarction
Stroke
Recurrent ischemia
Major bleeding
Duration of index hospitalization

Full Information

First Posted
March 9, 2015
Last Updated
July 10, 2020
Sponsor
Clinical Centre of Serbia
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1. Study Identification

Unique Protocol Identification Number
NCT02419833
Brief Title
Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients
Acronym
RIDDLE-NSTEMI
Official Title
Randomized Study of ImmeDiate Versus DeLayEd Invasive Intervention in Patients With Non ST-segment Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinical Centre of Serbia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
non-STEMI, immediate, delayed, PCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
323 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immediate invasive intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Delayed invasive intervention
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Immediate invasive intervention
Intervention Description
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
Intervention Name(s)
Delayed invasive intervention
Intervention Description
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
Device
Intervention Name(s)
Coronary artery stenting
Intervention Description
Implantation of coronary stents
Primary Outcome Measure Information:
Title
Composite of all-cause death or myocardial reinfarction
Time Frame
within 30 days of randomization
Secondary Outcome Measure Information:
Title
Composite of all-cause death, myocardial reinfarction or recurrent ischemia
Time Frame
within 30 days of randomization
Title
All-cause mortality
Time Frame
within 30 days, 1, 3 and 5 years after randomization
Title
Myocardial reinfarction
Time Frame
within 30 days, 1, 3 and 5 years after randomization
Title
Stroke
Time Frame
within 30 days, 1, 3 and 5 years after randomization
Title
Recurrent ischemia
Time Frame
within 30 days of randomization
Title
Major bleeding
Time Frame
within 30 days, 1, 3 and 5 years after randomization
Title
Duration of index hospitalization
Time Frame
at 30-day follow-up, the duration of hospital stay is assessed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: episode of chest pain occurring no longer than 24 hours prior to admission elevation of cardiac troponin I above the upper limit of normal (ULN) 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: age < 18 years persistent ST-segment elevation hemodynamic instability cardiogenic shock on admission life-threatening ventricular arrhythmias on admission refractory angina on admission active bleeding any contraindication for the use of dual antiplatelet therapy (DAPT) presence of comorbidities with life expectancy < 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Goran Stankovic, MD, PhD
Organizational Affiliation
Clinical Centre of Serbia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aleksandra Milosevic, MD
Organizational Affiliation
Clinical Centre of Serbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zorana Vasiljevic, MD, PhD
Organizational Affiliation
Clinical Centre of Serbia
Official's Role
Study Chair
Facility Information:
Facility Name
Clinical Centre of Serbia, Department of Cardiology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

Citations:
PubMed Identifier
26777321
Citation
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.
Results Reference
derived

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Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients

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