The Effect of Ischemic Postconditioning in Patients With STEMI Undergoing Primary PCI (DANAMI4-iPOST2)
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Denmark
The Heart Center, Rigshospitalet, University of Copenhagen
RECRUITING
Copenhagen
Contact Information
Primary
Thomas Engstrøm, DMSci
thomas.engstroem@regionh.dk
+4535458444
Backup
Jacob Lønborg, DMSci
jacob.thomsen.loenborg01@regionh.dk
+4535458176
Time Frame
Start Date: 2019-02-04
Estimated Completion Date: 2033-01-31
Participants
Target number of participants: 1800
Treatments
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
Placebo_comparator: Conventional
State of the art primary PCI in patients with TIMI0-1 will be performed, however thrombectomy will not be allowed
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark