Ischemic Postconditioning in STEMI Patients Treated With Primary PCI

ST Segment Elevation Myocardial Infarction Clinical Trial

— iPOST2  

Official title:

The Effect of Ischemic Postconditioning in Patients With STEMI Undergoing Primary PCI (DANAMI4-iPOST2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03787745
• Other study ID #: H-18051256
• Status: Recruiting
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: January 31, 2033

Study information

• Verified date: November 2023
• Source: Rigshospitalet, Denmark
• Contact: Thomas Engstrøm, DMSci
• Phone: +4535458444
• Email: thomas.engstroem[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: January 31, 2033
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST Segment Elevation Myocardial Infarction

Intervention

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

Locations

Country	Name	City	State
Denmark	The Heart Center, Rigshospitalet, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & 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, Jens — View Citation

Outcome

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