Acute Myocardial InfarctionPhase 1/2NCT00333320
Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
A Phase 1/2 study testing postconditioning in people with Acute Myocardial Infarction, run by French Cardiology Society at 1 site in France.
Trial summary
The purpose of this study is to determine whether brief periods of ischemia performed just at the time of reperfusion -postconditioning- can reduce coronary endothelial dysfunction and infarct size in humans Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- postconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to Nov 2011
- Phase
- Phase 1/2
- 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
- Acute myocardial infarction (<6 hours)
- Occlusion of a major coronary vessel
Who cannot join
- History of previous myocardial infarction
- History of Coronary Artery Bypass Grafting
- Need for Coronary Artery Bypass Grafting
- Stenosis not eligible for angioplasty
- Limited ischemic area
- Cardiogenic shock
Show all 10Show fewer
- Interventricular septum rupture
- Mitral regurgitation>2
- Ventricular tachycardia
- Atrioventricular block class II and III
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether brief periods of ischemia performed just at the time of reperfusion -postconditioning- can reduce coronary endothelial dysfunction and infarct size in humans
Read the detailed description
Desobstruction of the culprit artery after acute myocardial infarction allows to reduce the consequences of prolonged ischemia. However, it is now clearly established that reperfusion induces by itself severe myocardial injuries. Postconditioning has been described as an adaptive response triggered by a brief ischemia applied after a prolonged coronary occlusion. Several teams have reported that ischemia/reperfusion cycles allow to reduce infarct size in experimental models.
Different pathophysiological processes have been proposed to explain the beneficial effect of postconditioning. It has been reported that postconditioning reduces the inflammatory response, and activates cardioprotective signaling pathways (Akt, eNOS, p70S6K). In addition, an improvement of the endothelial function has been reported.
This controlled trial aim to study the potential beneficial effect of postconditioning in patients with acute myocardial infarction. Forty six patients will be included in the study and the culprit artery will be reoccluded three times for 1 minutes after desobstruction in one of the both groups after randomization of the patients.
The evaluation will be focused on the comparison of the coronary reserve after intracoronary adenosine injection. In addition, additional parameters will be used to study the effect of postconditioning on post-ischemic endothelial dysfunction: frequencies of low reflow and slow reflow situation, myocardial blush and regression of ST elevation. The effect of postconditioning on the left ventricular systolic function will be studied by Doppler tissue imaging and RMN.
- Conditions
- Acute Myocardial Infarction
- Being tested
- postconditioning, Control group
- Keywords
- acute myocardial infarction, postconditioning, coronary reserve, ejection fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postconditioningProcedure or surgery
patients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion
Control groupProcedure or surgery
Percutaneous coronary interventions were performed following international guidelines. No additional intervention was performed in the control group.
| Study group | Role | What they receive |
|---|---|---|
| - Control | Placebo comparator | Not described Receives: Procedure: Control group |
| -postconditioning group | Experimental | Not described Receives: Procedure: postconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
coronary reserve after intracoronary adenosine injection
Measured: Immediately after the postconditioning procedure
Secondary outcomes (5)
frequencies of low reflow and slow reflow situation
Measured: after postconditioning
regression of ST elevation
Measured: 1h and 24h after postconditioning
left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6)
Measured: day 1 and 6
left ventricular systolic function by RMN
Measured: day 8-12
myocardial blush
Measured: after postconditioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2006 (estimated)
- Study startSep 2006
- Primary completionJul 2010
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Le Corvoisier, MD, Principal investigator, Henri Mondor University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333320
- Sponsor's protocol ID
- POSTCONDITIONING
- Other IDs
- SFC-2006-02
- Status last verified
- Oct 2012
- First submitted
- 2 Jun 2006
- Last updated
- 23 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Effect of Ischemic Postconditioning During Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00333320
- Acronym / sponsor ID
- POSTCONDITIONING
- Conditions
- Acute Myocardial Infarction
- Keywords
- acute myocardial infarction, postconditioning, coronary reserve, ejection fraction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 5 Jun 2006 (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 purpose of this study is to determine whether brief periods of ischemia performed just at the time of reperfusion -postconditioning- can reduce coronary endothelial dysfunction and infarct size in humans
Detailed description
Desobstruction of the culprit artery after acute myocardial infarction allows to reduce the consequences of prolonged ischemia. However, it is now clearly established that reperfusion induces by itself severe myocardial injuries. Postconditioning has been described as an adaptive response triggered by a brief ischemia applied after a prolonged coronary occlusion. Several teams have reported that ischemia/reperfusion cycles allow to reduce infarct size in experimental models.
Different pathophysiological processes have been proposed to explain the beneficial effect of postconditioning. It has been reported that postconditioning reduces the inflammatory response, and activates cardioprotective signaling pathways (Akt, eNOS, p70S6K). In addition, an improvement of the endothelial function has been reported.
This controlled trial aim to study the potential beneficial effect of postconditioning in patients with acute myocardial infarction. Forty six patients will be included in the study and the culprit artery will be reoccluded three times for 1 minutes after desobstruction in one of the both groups after randomization of the patients.
The evaluation will be focused on the comparison of the coronary reserve after intracoronary adenosine injection. In addition, additional parameters will be used to study the effect of postconditioning on post-ischemic endothelial dysfunction: frequencies of low reflow and slow reflow situation, myocardial blush and regression of ST elevation. The effect of postconditioning on the left ventricular systolic function will be studied by Doppler tissue imaging and RMN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| - Control | Placebo comparator | Procedure: Control group |
| -postconditioning group | Experimental | Procedure: postconditioning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute myocardial infarction (<6 hours)
- Occlusion of a major coronary vessel
Key exclusion criteria (10 listed)
- History of previous myocardial infarction
- History of Coronary Artery Bypass Grafting
- Need for Coronary Artery Bypass Grafting
- Stenosis not eligible for angioplasty
- Limited ischemic area
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 |
|---|---|---|
| postconditioningpatients were treated by repeated cycles of cycles of reperfusion/ischemia at the end of the procedure within the first minute after reperfusion | Procedure or surgery | -postconditioning group |
| Control groupPercutaneous coronary interventions were performed following international guidelines. No additional intervention was performed in the control group. | Procedure or surgery | - Control |
Primary outcome
coronary reserve after intracoronary adenosine injection
Time frame: Immediately after the postconditioning procedure
5 secondary outcomes
frequencies of low reflow and slow reflow situation
Time frame: after postconditioning
regression of ST elevation
Time frame: 1h and 24h after postconditioning
left ventricular systolic function by Doppler tissue imaging (DAY 1 and 6)
Time frame: day 1 and 6
left ventricular systolic function by RMN
Time frame: day 8-12
myocardial blush
Time frame: after postconditioning
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 23 Oct 2012.
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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.
Philippe Le Corvoisier, MD principal investigator
Henri Mondor University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing postconditioning in people with Acute Myocardial Infarction, run by French Cardiology Society 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 2 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 23 Oct 2012. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
coronary reserve after intracoronary adenosine injection (time frame: Immediately after the postconditioning procedure). 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 23 Oct 2012.