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

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ClinicalTrials.gov Identifier: NCT02419833
Recruitment Status : Unknown
Verified April 2015 by Aleksandra Milosevic, Clinical Centre of Serbia.
Recruitment status was:  Active, not recruiting
First Posted : April 17, 2015
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
Aleksandra Milosevic, Clinical Centre of Serbia

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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Procedure: Immediate invasive intervention Procedure: Delayed invasive intervention Device: Coronary artery stenting Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 323 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Study of ImmeDiate Versus DeLayEd Invasive Intervention in Patients With Non ST-segment Elevation Myocardial Infarction
Study Start Date : September 2009
Actual Primary Completion Date : March 2013
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

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
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

Device: Coronary artery stenting
Implantation of coronary stents




Primary Outcome Measures :
  1. Composite of all-cause death or myocardial reinfarction [ Time Frame: within 30 days of randomization ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419833


Locations
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Serbia
Clinical Centre of Serbia, Department of Cardiology
Belgrade, Serbia, 11000
Sponsors and Collaborators
Clinical Centre of Serbia
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Aleksandra Milosevic, MD, Clinical Centre of Serbia
ClinicalTrials.gov Identifier: NCT02419833     History of Changes
Other Study ID Numbers: 440/VII/1
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Keywords provided by Aleksandra Milosevic, Clinical Centre of Serbia:
non-STEMI
immediate
delayed
PCI

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases