Myocardial InfarctionPhase 3RIRE-1NCT01390142
Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction
A Phase 3 study testing RIPer and RIPer + IPost in people with Myocardial Infarction, run by University Hospital, Angers at 1 site in France.
Trial summary
RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention… 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?
- RIPer and RIPer + IPost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2011to Mar 2013
- Phase
- Phase 3
- 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
- Age > 18
- ST-Segment elevation myocardial infarction <6h
- Written informed consent
Who cannot join
- Previous Q-wave myocardial infarction or previous coronary artery bypass graft
- Cardiogenic shock
- Cardiac arrest resuscitated before angioplasty
- Infarct related artery : circumflex coronary artery, right coronary artery after segment 3, left main, diagonal and marginal branches, and all coronary artery with jeopardized myocardium estimated too small.
- TIMI 2 or 3 before angioplasty
- Collateral branches Rentrop >1
Show all 10Show fewer
- TIMI 0 or 1 flow grade after PCI
- Any contraindications to magnetic resonance imaging
- Allergy to gadolinium
- Patient refusal / patient not having provided written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)
RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a combined approach remote ischemic preconditioning and local ischemic postconditioning can further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.
Read the detailed description
In the management of STEMI, prompt reperfusion of the jeopardized myocardium is the most effective way to limit infarct size, which is a major determinant of morbidity and mortality. However, restoration of blood flow may paradoxically have deleterious consequences and lead to lethal myocardial ischemia-reperfusion injury. Local ischemic postconditioning (IPost) and remote ischemic preconditioning (RIPer) are promising methods to decrease ischemia-reperfusion injury.
The hypothesis tested in this research proposal is that RIPer initiated at the time of the admission in the cathlab reduces infarct size in STEMI patients treated with PCI. Furthermore, the investigators will determine whether a combined approach RIPer + IPost can further reduce infarct size.
- Conditions
- Myocardial Infarction
- Being tested
- Control, RIPer, RIPer + IPost
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlProcedure or surgery
Deflated blood pressure cuff placed on upper arm for 30min
RIPerProcedure or surgery
Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total.
RIPer + IPostProcedure or surgery
Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total. Within the first minute of re-established coronary flow by primo-stenting, the same balloon is re-inflated for 1 min and then deflated for 1min. This procedure of balloon inflation/deflation is repeated 4 times in total.
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Not described Receives: Procedure: Control |
| RIPer | Active comparator | Remote ischemic preconditioning Receives: Procedure: RIPer |
| RIPer + IPost | Active comparator | Remote ischemic preconditioning and Local ischemic postconditioning Receives: Procedure: RIPer + IPost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infarct size
Infarct size as assessed by 72 hours area under curve serum CK-MB and cardiac magnetic resonance imaging at 3-month follow-up
Measured: 3 months
Secondary outcomes (2)
Microvascular obstruction
Microvascular obstruction as assessed by cardiac magnetic resonance imaging at 5-day follow-up
Measured: 5 days
Left ventricular remodeling
Left ventricular remodeling as assessed by cardiac magnetic resonance imaging at 5-day and 3-month follow-up
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Fédération Française de Cardiologie, Société Française de Cardiologie
- Responsible party
- Sponsor
- Investigators
- Fabrice Prunier, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390142
- Sponsor's protocol ID
- PHRC 2011-06
- Acronym
- RIRE-1
- Status last verified
- Oct 2013
- First submitted
- 6 Jul 2011
- Last updated
- 18 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Preconditioning Combined to Local Ischemic Postconditioning in Acute Myocardial Infarction (RIRE-1)
- ClinicalTrials.gov ID
- NCT01390142
- Acronym / sponsor ID
- RIRE-1 / PHRC 2011-06
- Conditions
- Myocardial Infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Fédération Française de Cardiologie, Société Française de Cardiologie
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Jul 2011 (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.
RIRE-1 is a randomized, open-label with blinded end-point study that will test the hypothesis that remote ischemic preconditioning initiated at the time of the admission in the cathlab reduces infarct size in ST-segment elevation myocardial infarction (STEMI) patients treated with percutaneous coronary intervention (PCI). Furthermore, it will determine whether a combined approach remote ischemic preconditioning and local ischemic postconditioning can further reduce infarct size. Infarct size will be determined by cardiac magnetic resonance imaging at 3-month follow-up and with 72 hours area under curve of CK-MB.
Detailed description
In the management of STEMI, prompt reperfusion of the jeopardized myocardium is the most effective way to limit infarct size, which is a major determinant of morbidity and mortality. However, restoration of blood flow may paradoxically have deleterious consequences and lead to lethal myocardial ischemia-reperfusion injury. Local ischemic postconditioning (IPost) and remote ischemic preconditioning (RIPer) are promising methods to decrease ischemia-reperfusion injury.
The hypothesis tested in this research proposal is that RIPer initiated at the time of the admission in the cathlab reduces infarct size in STEMI patients treated with PCI. Furthermore, the investigators will determine whether a combined approach RIPer + IPost can further reduce infarct size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Procedure: Control |
| RIPer | Active comparator | Procedure: RIPerRemote ischemic preconditioning |
| RIPer + IPost | Active comparator | Procedure: RIPer + IPostRemote ischemic preconditioning and Local ischemic postconditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18
- ST-Segment elevation myocardial infarction <6h
- Written informed consent
Key exclusion criteria (10 listed)
- Previous Q-wave myocardial infarction or previous coronary artery bypass graft
- Cardiogenic shock
- Cardiac arrest resuscitated before angioplasty
- Infarct related artery : circumflex coronary artery, right coronary artery after segment 3, left main, diagonal and marginal branches, and all coronary artery with jeopardized myocardium estimated too small.
- TIMI 2 or 3 before angioplasty
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 |
|---|---|---|
| ControlDeflated blood pressure cuff placed on upper arm for 30min | Procedure or surgery | Control |
| RIPerBlood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total. | Procedure or surgery | RIPer |
| RIPer + IPostBlood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total. Within the first minute of re-established coronary flow by primo-stenting, the same balloon is re-inflated for 1 min and then deflated for 1min. This procedure of balloon inflation/deflation is repeated 4 times in total. | Procedure or surgery | RIPer + IPost |
Primary outcome
Infarct size
Time frame: 3 months
Infarct size as assessed by 72 hours area under curve serum CK-MB and cardiac magnetic resonance imaging at 3-month follow-up
2 secondary outcomes
Microvascular obstruction
Time frame: 5 days
Left ventricular remodeling
Time frame: 3 months
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 18 Oct 2013.
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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.
Fabrice Prunier, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RIPer and RIPer + IPost in people with Myocardial Infarction, run by University Hospital, Angers at 1 site in France.
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 10 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 18 Oct 2013. 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Infarct size (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2013.