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

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ClinicalTrials.gov Identifier: NCT03787745
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
ST Segment Elevation Myocardial Infarction Procedure: Ischemic postconditioning Procedure: Conventional Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, placebo controlled
Masking: Single (Outcomes Assessor)
Masking Description: All study personell involved in outcome assessment will be blinded to the treatment employed
Primary Purpose: Treatment
Official Title: The Effect of Ischemic Postconditioning in Patients With STEMI Undergoing Primary PCI
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : January 31, 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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
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

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787745


Contacts
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Contact: Thomas Engstrøm, DMSci +4535458444 thomas.engstroem@regionh.dk
Contact: Jacob Lønborg, DMSci +4535458176 jacob.thomsen.loenborg01@regionh.dk

Locations
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Denmark
The Heart Center, Rigshospitalet, University of Copenhagen Recruiting
Copenhagen, Denmark, 2100
Contact: Thomas Engstrøm, DMSci         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Study Chair: Thomas Engstrøm, DMSci Rigshospitalet, Denmark

Publications of Results:
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Responsible Party: Thomas Engstrom, Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03787745     History of Changes
Other Study ID Numbers: H-18051256
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thomas Engstrom, Rigshospitalet, Denmark:
Primary PCI
Ischemic postconditioning
Clinical outcome

Additional relevant MeSH terms:
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Infarction
Myocardial Infarction
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases