Clinical trial NCT03787745: Ischemic Postconditioning in STEMI Patients Treated With Primary PCI
Official title: The Effect of Ischemic Postconditioning in Patients With STEMI Undergoing Primary PCI (DANAMI4-iPOST2)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ST Segment Elevation Myocardial Infarction
Keywords: Primary PCI
Ischemic postconditioning
Clinical outcome
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, placebo controlled
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: All cause mortality or hospitalization for heart failure
timeFrame: 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:
measure: All cause mortality
timeFrame: 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
measure: Percentage of patients hospitalized for heart failure
timeFrame: 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
measure: Percentage of patients with myocardial infarction
timeFrame: 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
measure: Cardiovascular death
timeFrame: 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
measure: Percentage of patients with stroke
timeFrame: 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
measure: Percentage of patients with a combination of all-cause mortality, hospitalization for heart failure, new myocardial infarction and stroke/transitory cerebral ischemia
timeFrame: 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
measure: Percentage of patients with a combination of hospitalization for heart failure and cardiovascular death
timeFrame: 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
measure: Danish eq5d5l standard Quality of life
timeFrame: 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: The Heart Center, Rigshospitalet, University of Copenhagen
Study officials:
affiliation: Rigshospitalet, Denmark
name: Thomas Engstrøm, DMSci
role: STUDY_CHAIR
References:
citation: 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.