Ischemic Postconditioning in STEMI Patients Treated With Primary PCI

Overview

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 Title of Study: “The Effect of Ischemic Postconditioning in Patients With STEMI Undergoing Primary PCI”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 31, 2024

Detailed 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.

Interventions

  • Procedure: Ischemic postconditioning
    • After 60 seconds of reperfusion, ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed
  • Procedure: Conventional
    • State of the art primary PCI, however thrombectomy is not allowed

Arms, Groups and Cohorts

  • Active Comparator: Ischemic postconditioning
    • 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
  • Placebo Comparator: Conventional
    • State of the art primary PCI in patients with TIMI0-1 will be performed, however thrombectomy will not be allowed

Clinical Trial Outcome Measures

Primary Measures

  • All cause mortality or hospitalization for heart failure
    • 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 months
    • Composite endpoint of all cause mortality or hospitalization for heart failure which ever occur first

Secondary Measures

  • 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 months
    • All cause mortality
  • Percentage of patients hospitalized for heart failure
    • 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 months
    • Any hospitalization for heart failure occurring after the index STEMI
  • Percentage of patients with myocardial infarction
    • 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 months
    • Any myocardial infarction occurring after the index STEMI
  • 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 months
    • Cardiovascular death
  • Percentage of patients with stroke
    • 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 months
    • An acute episode of focal or global neurological dysfunction caused by brain injury
  • Percentage of patients with a combination of all-cause mortality, hospitalization for heart failure, new myocardial infarction and stroke/transitory cerebral ischemia
    • 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 months
    • Composite endpoint of all-cause mortality, hospitalization for heart failure, new myocardial infarction and stroke/transitory cerebral ischemia
  • Percentage of patients with a combination of hospitalization for heart failure and 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 months
    • A composite of hospitalization for heart failure and cardiovascular death
  • Danish eq5d5l standard Quality of life
    • Time Frame: 1 year
    • Self assesed quality of life after the Danish eq5d5l standard scale (1 worst score -100 best score)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rigshospitalet, Denmark
  • Provider of Information About this Clinical Study
    • Principal Investigator: Thomas Engstrom, Professor – Rigshospitalet, Denmark
  • Overall Official(s)
    • Thomas Engstrøm, DMSci, Study Chair, Rigshospitalet, Denmark
  • Overall Contact(s)
    • Thomas Engstrøm, DMSci, +4535458444, thomas.engstroem@regionh.dk

Citations Reporting on Results

Engstrøm T, Kelbæk H, Helqvist S, Høfsten DE, Kløvgaard L, Clemmensen P, Holmvang L, Jørgensen E, Pedersen F, Saunamaki K, Ravkilde J, Tilsted HH, Villadsen A, Aarøe J, Jensen SE, Raungaard B, Bøtker 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, Lønborg J, Køber 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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.