Myocardial Reperfusion InjuryPhase 2PRIMENCT01483755
Delayed Postconditioning
A Phase 2 study testing Postconditioning and Percutaneaous intervention in people with Myocardial Reperfusion Injury, run by Hospices Civils de Lyon at 5 sites in France.
Trial summary
The investigators previously reported that angioplasty postconditioning reduces infarct size (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Reperfusion Injury
- What is being tested?
- Postconditioning and Percutaneaous intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 5 sitesFrance
- Study dates
- Jul 2009to Jun 2012
- Phase
- Phase 2
- 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
- Patient > 18 years old
- Male or female
- Presenting first myocardial infarction, with the beginning of pains < 12 hours,
- Requiring a revascularisation by primary angioplasty or " rescue " (after failure of thrombolysis) on LAD or RCA (not Circumflex coronary artery).
- TIMI flow grade at admission of 2 or 3
- LV angiography (RAO30°) before angioplasty.
Who cannot join
- Cardiac arrest before the angioplasty
- Cardiogenic shock
- Occlusion of the artery circumflex responsible for the infarction
- Visible collaterals to the area at risk
- Magnetic resonance imaging: contra indication
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Service de Cardiologie, CHU d'Angers
Angers, 49933
Service d'explorations Fonctionnelles Cardiovasculaires, Hôpital Cardiologique Louis Pradel
Bron, 69677
Service de Cardiologie, Hôpital Arnaud de Villeneuve
Montpellier, 34295
Service de Cardiologie, Hôpital Emile Müller
Mulhouse, 68051
Service de Cardiologie, Hôpital Rangueil
Toulouse, 31059
About this study
Official title: Delayed Angioplasty Postconditioning in STEMI Patients
The investigators previously reported that angioplasty postconditioning reduces infarct size (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital admission. Animal studies have suggested that the time window for applying brief episodes of ischemia and reperfusion aimed at triggering postconditioning's protection is very narrow, i.e. does not expand beyond 1 minute after reflow. We sought to address whether this window might be larger in humans, i.e. whether STEMI patients might be protected several minutes after undergoing spontaneous reperfusion before admission coronary angiography.
Therefore, STEMI patients (onset of chest pain less than 12 hours) with a TIMI flow grade > 1 were eligible for that study. Angioplasty postconditioning was completed as already published and infarct size was assessed by measuring cardiac enzymes release.
- Conditions
- Myocardial Reperfusion Injury
- Being tested
- Postconditioning, Percutaneaous intervention
- Keywords
- Myocardial infarction, Postconditioning
- Medical subject headings
- Myocardial Reperfusion Injury, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PostconditioningProcedure or surgery
Postconditioning consists of four cycles of one minute balloon inflation followed by one minute of balloon deflation, with the initial inflation being started within the first minute after reopening of the culprit coronary artery.
Percutaneaous interventionProcedure or surgery
Conventional primary percutaneaous intervention
| Study group | Role | What they receive |
|---|---|---|
| Postconditionned | Experimental | 36 postconditionned patients Receives: Procedure: Postconditioning |
| Conventional intervention | Sham comparator | 36 control patients with conventional primary percutaneaous intervention (PCI) Receives: Procedure: Percutaneaous intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of the infarct
Size of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion
Measured: Day 5 post reperfusion
Secondary outcomes (1)
Contractile functional recovery
Contractile functional recovery estimated by echocardiography at 6th month versus before discharge.
Measured: 6 months after reperfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startJul 2009
- Primary completionJun 2012
- Study completionJun 2012
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 Reperfusion InjuryStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483755
- Sponsor's protocol ID
- 2008.536/37
- Acronym
- PRIME
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2011
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Roubille F, Mewton N, Elbaz M, Roth O, Prunier F, Cung TT, Piot C, Roncalli J, Rioufol G, Bonnefoy-Cudraz E, Wiedemann JY, Furber A, Jacquemin L, Willoteaux S, Abi-Khallil W, Sanchez I, Finet G, Sibellas F, Ranc S, Boussaha I, Croisille P, Ovize M. No post-conditioning in the human heart with thrombolysis in myocardial infarction flow 2-3 on admission. Eur Heart J. 2014 Jul 1;35(25):1675-82. doi: 10.1093/eurheartj/ehu054. Epub 2014 Feb 28.
PubMed 24585265
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Angioplasty Postconditioning in STEMI Patients
- ClinicalTrials.gov ID
- NCT01483755
- Acronym / sponsor ID
- PRIME / 2008.536/37
- Conditions
- Myocardial Reperfusion Injury
- Keywords
- Myocardial infarction, Postconditioning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 Dec 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.
The investigators previously reported that angioplasty postconditioning reduces infarct size (cardiac enzyme release) in STEMI patients with a fully occluded coronary artery at hospital admission. Animal studies have suggested that the time window for applying brief episodes of ischemia and reperfusion aimed at triggering postconditioning's protection is very narrow, i.e. does not expand beyond 1 minute after reflow. We sought to address whether this window might be larger in humans, i.e. whether STEMI patients might be protected several minutes after undergoing spontaneous reperfusion before admission coronary angiography.
Therefore, STEMI patients (onset of chest pain less than 12 hours) with a TIMI flow grade > 1 were eligible for that study. Angioplasty postconditioning was completed as already published and infarct size was assessed by measuring cardiac enzymes release.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postconditionned | Experimental | Procedure: Postconditioning36 postconditionned patients |
| Conventional intervention | Sham comparator | Procedure: Percutaneaous intervention36 control patients with conventional primary percutaneaous intervention (PCI) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient > 18 years old
- Male or female
- Presenting first myocardial infarction, with the beginning of pains < 12 hours,
- Requiring a revascularisation by primary angioplasty or " rescue " (after failure of thrombolysis) on LAD or RCA (not Circumflex coronary artery).
- TIMI flow grade at admission of 2 or 3
Key exclusion criteria (5 listed)
- Cardiac arrest before the angioplasty
- Cardiogenic shock
- Occlusion of the artery circumflex responsible for the infarction
- Visible collaterals to the area at risk
- Magnetic resonance imaging: contra indication
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 |
|---|---|---|
| PostconditioningPostconditioning consists of four cycles of one minute balloon inflation followed by one minute of balloon deflation, with the initial inflation being started within the first minute after reopening of the culprit coronary artery. | Procedure or surgery | Postconditionned |
| Percutaneaous interventionConventional primary percutaneaous intervention | Procedure or surgery | Conventional intervention |
Primary outcome
Size of the infarct
Time frame: Day 5 post reperfusion
Size of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion
1 secondary outcome
Contractile functional recovery
Time frame: 6 months after reperfusion
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 19 Dec 2025.
- Results publication: PubMed 24585265Roubille F, Mewton N, Elbaz M, Roth O, Prunier F, Cung TT, Piot C, Roncalli J, Rioufol G, Bonnefoy-Cudraz E, Wiedemann JY, Furber A, Jacquemin L, Willoteaux S, Abi-Khallil W, Sanchez I, Finet G, Sibellas F, Ranc S, Boussaha I, Croisille P, Ovize M. No post-conditioning in the human heart with thrombolysis in myocardial infarction flow 2-3 on admission. Eur Heart J. 2014 Jul 1;35(25):1675-82. doi: 10.1093/eurheartj/ehu054. Epub 2014 Feb 28.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Postconditioning and Percutaneaous intervention in people with Myocardial Reperfusion Injury, run by Hospices Civils de Lyon at 5 sites 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 6 inclusion and 5 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 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Size of the infarct (time frame: Day 5 post reperfusion). 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 NCT01483755, 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 19 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.