Optimizing treatment for heart attack using advanced techniques
The STEMI Optimization Trial - Ischemic Postconditioning (DANAMI4-iPOST) and Intravascular Ultrasound Guided PCI in STEMI (DANAMI4-iSTEMI)
NA · Rigshospitalet, Denmark · NCT04775914
This study is testing if a new way of treating heart attacks using special techniques can help people with severe chest pain recover better than the usual treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 2500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 1 site (Copenhagen, Capital Region) |
| Trial ID | NCT04775914 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of ischemic postconditioning (iPOST) combined with intravascular ultrasound (IVUS) guidance during percutaneous coronary intervention (PCI) for patients experiencing ST-segment elevation myocardial infarction (STEMI). The goal is to determine if these advanced techniques can improve clinical outcomes compared to standard PCI methods. Patients with acute chest pain and specific ST elevation criteria will be enrolled, and their treatment will be closely monitored to assess the benefits of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who present with acute chest pain and meet specific criteria for STEMI.
Not a fit: Patients with a pre-PCI TIMI flow of 0 or 1, those who are pregnant, or individuals unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better recovery outcomes for patients suffering from heart attacks.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for heart attack patients using advanced PCI techniques.
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. Exclusion Criteria (iPOST2): Pre-PCI TIMI flow 0 or 1 Potential pregnancy Inability to provide informed consent Unwillingness to consent Unavoidable to use thrombectomy Spontaneous coronary artery dissection Time from symptoms onset to PPCI \> 12 hours Culprit in bypass graft Other reason for not including the patient Exclusion Criteria (iSTEMI): Potential pregnancy Inability to understand information in order to provide informed consent Unwillingness to consent Spontaneous coronary artery dissection Time from symptoms inset to PPCI \> 12 hours Culprit in bypass graft Other reason
Where this trial is running
Copenhagen, Capital Region
- Heart Center, Rigshospitalet — Copenhagen, Capital Region, Denmark (RECRUITING)
Study contacts
- Study coordinator: Thomas Engstrøm, MD PhD DSci
- Email: Thomas.Engstroem@regionh.dk
- Phone: +45 3545 8444
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.
Conditions: ST Elevation Myocardial Infarction, Primary PCI, Coronary angiography, Intravascular ultra sound