Ischemic Postconditioning in STEMI Patients Treated With Primary PCI (iPOST2)

Rigshospitalet

Status: Enrolling

Conditions: ST Segment Elevation Myocardial Infarction

Treatments: Procedure: Ischemic postconditioning; Procedure: Conventional

Study type: Interventional

Funder types: Other

Identifiers

NCT03787745

H-18051256

Details and patient eligibility

About

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

Full description

Myocardial reperfusion with the use primary percutaneous coronary intervention (PCI) is effective, but restoration of blood flow may itself jeopardize the myocardium, a phenomenon known as reperfusion injury.

In ischemic postconditioning (iPOST), repetitive interruptions of blood flow to the injured region applied after initial reperfusion, has been shown favorable with different modalities such as biomarkers, echocardiography and cardiac magnetic resonance.

However, the largest trial to date (DANAMI3-iPOST) failed to show clinical favor of iPOST when compared to conventional PCI. Importantly, however, in DANAMI3-iPOST thrombectomy was allowed and this might have impaired postconditioning, since thrombectomy itself creates reperfusion and thus reperfusion damage. Analysis of the fraction of DANAMI3-iPOST patients not undergoing thrombectomy showed a remarkable 45% reduction in death and heart failure in favor of postconditioning.

iPOST2 will investigate in a randomized, prospective and adequately powered trial the effect of iPOST without thrombectomy compared to conventional PCI on the development of heart failure and death in STEMI patients.

Enrollment: 1,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Potential pregnancy
• Refusal to participate
• OHCA without subsequent consciousness despite ROSC
• Thrombectomy considered unavoidable

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,800 participants in 2 patient groups, including a placebo group

Ischemic postconditioning

Active Comparator group

Description:

In addition to state of the art primary PCI in patients with TIMI0-1 ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed, however thrombectomy will not be allowed

Treatment:

Procedure: Ischemic postconditioning

Conventional

Placebo Comparator group

Description:

State of the art primary PCI in patients with TIMI0-1 will be performed, however thrombectomy will not be allowed

Treatment:

Procedure: Conventional