Ischemic Postconditioning in STEMI Patients Treated With Primary PCI

NCT03787745 | Recruiting DMC

• 1 other identifier: H-18051256
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

ST Segment Elevation Myocardial Infarction

Keywords

Primary PCI; Ischemic postconditioning; Clinical outcome

Outcome Measures

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

  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 months

Secondary Outcomes (8)

• All cause mortality

  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 months

• Percentage of patients hospitalized for heart failure

  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 months

• Percentage of patients with myocardial infarction

  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 months

• Cardiovascular death

  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 months

• Percentage of patients with stroke

  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 months

Study Arms (2)

Ischemic postconditioning

ACTIVE COMPARATOR

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

Procedure: Ischemic postconditioning

Conventional

PLACEBO COMPARATOR

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

Procedure: Conventional

Interventions

Ischemic postconditioning PROCEDURE

After 60 seconds of reperfusion, ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed

Ischemic postconditioning

Conventional PROCEDURE

State of the art primary PCI, however thrombectomy is not allowed

Conventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

The Heart Center, Rigshospitalet, University of Copenhagen

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (1)

• Engstrom T, Kelbaek H, Helqvist S, Hofsten DE, Klovgaard L, Clemmensen P, Holmvang L, Jorgensen E, Pedersen F, Saunamaki K, Ravkilde J, Tilsted HH, Villadsen A, Aaroe J, Jensen SE, Raungaard B, Botker HE, Terkelsen CJ, Maeng M, Kaltoft A, Krusell LR, Jensen LO, Veien KT, Kofoed KF, Torp-Pedersen C, Kyhl K, Nepper-Christensen L, Treiman M, Vejlstrup N, Ahtarovski K, Lonborg J, Kober L; Third Danish Study of Optimal Acute Treatment of Patients With ST Elevation Myocardial Infarction-Ischemic Postconditioning (DANAMI-3-iPOST) Investigators. Effect of Ischemic Postconditioning During Primary Percutaneous Coronary Intervention for Patients With ST-Segment Elevation Myocardial Infarction: A Randomized Clinical Trial. JAMA Cardiol. 2017 May 1;2(5):490-497. doi: 10.1001/jamacardio.2017.0022.

  PMID: 28249094 RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Ischemic Postconditioning; Congresses as Topic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Therapeutics; Organizations; Health Care Economics and Organizations

Study Officials

• Thomas Engstrøm, DMSci

  Rigshospitalet, Denmark

  STUDY CHAIR

Central Study Contacts

Thomas Engstrøm, DMSci

CONTACT

+4535458444; thomas.engstroem@regionh.dk

Jacob Lønborg, DMSci

CONTACT

+4535458176; jacob.thomsen.loenborg01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All study personell involved in outcome assessment will be blinded to the treatment employed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, randomized, placebo controlled

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 26, 2018
• Study Start: February 4, 2019
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): January 31, 2033
• Last Updated: March 30, 2026

Record last verified: 2025-05

Locations

DK (1)