Myocardial InfarctionRIDDLE-NSTEMINCT02419833
Immediate Versus Delayed Invasive Intervention for Non-STEMI Patients
A study testing Immediate invasive intervention, Delayed invasive intervention and Coronary artery stenting in people with Myocardial Infarction, run by Clinical Centre of Serbia at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Immediate invasive intervention, Delayed invasive intervention and Coronary artery stenting
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 323 participants
- Where
- 1 siteSerbia
- Study dates
- Sep 2009to Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- age < 18 years
- persistent ST-segment elevation
- hemodynamic instability
- cardiogenic shock on admission
- life-threatening ventricular arrhythmias on admission
- refractory angina on admission
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- active bleeding
- any contraindication for the use of dual antiplatelet therapy (DAPT)
- presence of comorbidities with life expectancy < 6 months
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Clinical Centre of Serbia, Department of Cardiology
Belgrade, 11000
About this study
Official title: 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.
- Conditions
- Myocardial Infarction
- Being tested
- Immediate invasive intervention, Delayed invasive intervention, Coronary artery stenting
- Keywords
- non-STEMI, immediate, delayed, PCI
- Medical subject headings
- Myocardial Infarction, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate invasive interventionProcedure or surgery
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 interventionProcedure or surgery
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 stentingDevice
Implantation of coronary stents
| Study group | Role | What they receive |
|---|---|---|
| Immediate invasive intervention | Experimental | 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 Receives: Procedure: Immediate invasive intervention; Device: Coronary artery stenting |
| Delayed invasive intervention | Active comparator | 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 Receives: Procedure: Delayed invasive intervention; Device: Coronary artery stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of all-cause death or myocardial reinfarction
Measured: within 30 days of randomization
Secondary outcomes (7)
Composite of all-cause death, myocardial reinfarction or recurrent ischemia
Measured: within 30 days of randomization
All-cause mortality
Measured: within 30 days, 1, 3 and 5 years after randomization
Myocardial reinfarction
Measured: within 30 days, 1, 3 and 5 years after randomization
Stroke
Measured: within 30 days, 1, 3 and 5 years after randomization
Recurrent ischemia
Measured: within 30 days of randomization
Major bleeding
Measured: within 30 days, 1, 3 and 5 years after randomization
Duration of index hospitalization
Measured: at 30-day follow-up, the duration of hospital stay is assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startSep 2009
- Primary completionMar 2013
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Centre of Serbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Milosevic, Clinical Centre of Serbia
- Investigators
- Goran Stankovic, MD, PhD, Study director, Clinical Centre of SerbiaAleksandra Milosevic, MD, Principal investigator, Clinical Centre of SerbiaZorana Vasiljevic, MD, PhD, Study chair, Clinical Centre of Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02419833
- Sponsor's protocol ID
- 440/VII/1
- Acronym
- RIDDLE-NSTEMI
- Status last verified
- Jul 2020
- First submitted
- 9 Mar 2015
- Last updated
- 13 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26777321
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of ImmeDiate Versus DeLayEd Invasive Intervention in Patients With Non ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT02419833
- Acronym / sponsor ID
- RIDDLE-NSTEMI / 440/VII/1
- Conditions
- Myocardial Infarction
- Keywords
- non-STEMI, immediate, delayed, PCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Clinical Centre of SerbiaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate invasive intervention | Experimental | Procedure: Immediate invasive intervention, Device: Coronary artery stentingInvasive 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 |
| Delayed invasive intervention | Active comparator | Procedure: Delayed invasive intervention, Device: Coronary artery stentingInvasive 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- age < 18 years
- persistent ST-segment elevation
- hemodynamic instability
- cardiogenic shock on admission
- life-threatening ventricular arrhythmias on admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate invasive interventionInvasive 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 | Procedure or surgery | Immediate invasive intervention |
| Delayed invasive interventionInvasive 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 | Procedure or surgery | Delayed invasive intervention |
| Coronary artery stentingImplantation of coronary stents | Device | Delayed invasive intervention, Immediate invasive intervention |
Primary outcome
Composite of all-cause death or myocardial reinfarction
Time frame: within 30 days of randomization
7 secondary outcomes
Composite of all-cause death, myocardial reinfarction or recurrent ischemia
Time frame: within 30 days of randomization
All-cause mortality
Time frame: within 30 days, 1, 3 and 5 years after randomization
Myocardial reinfarction
Time frame: within 30 days, 1, 3 and 5 years after randomization
Stroke
Time frame: within 30 days, 1, 3 and 5 years after randomization
Recurrent ischemia
Time frame: within 30 days of randomization
Major bleeding
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Derived from this study: PubMed 26777321Milosevic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Goran Stankovic, MD, PhD study director
Clinical Centre of Serbia
Aleksandra Milosevic, MD principal investigator
Clinical Centre of Serbia
Zorana Vasiljevic, MD, PhD study chair
Clinical Centre of Serbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate invasive intervention, Delayed invasive intervention and Coronary artery stenting in people with Myocardial Infarction, run by Clinical Centre of Serbia at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of all-cause death or myocardial reinfarction (time frame: within 30 days of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02419833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2020; AzTrials last refreshed its copy on 1 Nov 2026.