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NCT Number: NCT02419833

Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Centre of Serbia, Department of Cardiology

Belgrade, 11000, Serbia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate invasive intervention

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

Delayed invasive intervention

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

Device

Implantation of coronary stents

Primary outcomes

  1. Composite of all-cause death or myocardial reinfarction

    Time frame: within 30 days of randomization

Secondary outcomes

  1. Composite of all-cause death, myocardial reinfarction or recurrent ischemia

    Time frame: within 30 days of randomization

  2. All-cause mortality

    Time frame: within 30 days, 1, 3 and 5 years after randomization

  3. Myocardial reinfarction

    Time frame: within 30 days, 1, 3 and 5 years after randomization

  4. Stroke

    Time frame: within 30 days, 1, 3 and 5 years after randomization

  5. Recurrent ischemia

    Time frame: within 30 days of randomization

  6. Major bleeding

    Time frame: within 30 days, 1, 3 and 5 years after randomization

  7. Duration of index hospitalization

    Time frame: at 30-day follow-up, the duration of hospital stay is assessed

Sponsors and collaborators

Lead sponsor

Clinical Centre of Serbia

Other

Registry information

Official study title

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

Acronym: RIDDLE-NSTEMI

Important dates

Study start
2009
Primary completion
2013
Study completion
2018
First posted
Apr 17, 2015
Registry last updated
Jul 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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