Ischemic Postconditioning in STEMI Patients Treated With Primary PCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRigshospitalet, Denmark
About this trial
In a prospective, randomized clinical trial the iPOST2 trial will determine whether ischemic postconditioning reduces reperfusion injury and this will translate into improved clinical outcome of heart failure and death for STEMI patients who present with TIMI0-1 undergoing primary PCI
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Acute onset of chest pain with < 12 hours duration
STEMI as characterized by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV ST-segment elevation in the limb lead (II, III and aVF, I, aVL) and V4-V6 or ST depression in 2 or more V1 through V4 leads indicating posterior AMI.
TIMI flow 0-1 in infarct related artery
Disqualifiers
Potential pregnancy
Refusal to participate
OHCA without subsequent consciousness despite ROSC
Thrombectomy considered unavoidable
Trial design
Design model
Parallel
Treatments tested in this trial
Ischemic postconditioning
Procedure/SurgeryAfter 60 seconds of reperfusion, ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed
Conventional
Procedure/SurgeryState of the art primary PCI, however thrombectomy is not allowed
Treatment groups
1,800 Participants
are divided into 2 treatment groupsGroup A: Ischemic postconditioningActive comparator 1 intervention
Group B: ConventionalPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
All cause mortality or hospitalization for heart failure
Composite endpoint of all cause mortality or hospitalization for heart failure which ever occur first
Time frame
From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 monthsSecondary outcomes
1
All cause mortality
All cause mortality
Time frame
From date of randomization until the date of first documented death from any cause assessed up to 280 events have been adjudicated or up to 36 months2
Percentage of patients hospitalized for heart failure
Any hospitalization for heart failure occurring after the index STEMI
Time frame
From date of randomization until the date of first documented hospitalization for heart failure assessed up to 280 events have been adjudicated or up to 36 months3
Percentage of patients with myocardial infarction
Any myocardial infarction occurring after the index STEMI
Time frame
From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 months4
Cardiovascular death
Cardiovascular death
Time frame
From date of randomization until the date of first documented hospitalization for heart failure or date of death from any cause, whichever came first, assessed up to 280 events have been adjudicated or up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov