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Delayed Postconditioning

Delayed Angioplasty Postconditioning in STEMI Patients

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01483755
Acronym
PRIME
Enrollment
72
Registered
2011-12-01
Start date
2009-07-31
Completion date
2012-06-30
Last updated
2025-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Reperfusion Injury

Keywords

Myocardial infarction, Postconditioning

Brief 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. 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.

Interventions

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.

PROCEDUREPercutaneaous intervention

Conventional primary percutaneaous intervention

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Size of the infarctDay 5 post reperfusionSize of the infarct estimated by magnetic resonance imaging at day 5 post-reperfusion

Secondary

MeasureTime frameDescription
Contractile functional recovery6 months after reperfusionContractile functional recovery estimated by echocardiography at 6th month versus before discharge.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026