Using ischemic postconditioning to improve outcomes in heart attack patients
The Effect of Ischemic Postconditioning in Patients With STEMI Undergoing Primary PCI (DANAMI4-iPOST2)
This study is testing if a new method called ischemic postconditioning can help heart attack patients recover better and reduce the risk of heart failure after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT03787745 on ClinicalTrials.gov |
What this trial studies
The iPOST2 trial is a prospective, randomized clinical trial aimed at determining whether ischemic postconditioning can reduce reperfusion injury and improve clinical outcomes in patients with ST Segment Elevation Myocardial Infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). This approach involves repetitive interruptions of blood flow to the injured heart region after initial reperfusion. The trial specifically excludes patients who undergo thrombectomy, as previous studies indicated that this may interfere with the benefits of postconditioning. By focusing on patients with TIMI flow 0-1, the study seeks to provide clearer insights into the effectiveness of ischemic postconditioning in reducing heart failure and mortality rates.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who present with acute chest pain and have a confirmed diagnosis of STEMI with TIMI flow 0-1.
Not a fit: Patients who are pregnant, have experienced out-of-hospital cardiac arrest without regaining consciousness, or require thrombectomy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rates of heart failure and death in STEMI patients.
How similar studies have performed: While previous studies like DANAMI3-iPOST did not show significant benefits, the iPOST2 trial aims to clarify the effectiveness of ischemic postconditioning without thrombectomy, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Copenhagen
- The Heart Center, Rigshospitalet, University of Copenhagen — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Thomas Engstrøm, DMSci
- Email: thomas.engstroem@regionh.dk
- Phone: +4535458444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.