Status:
COMPLETED
Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With Acute Myocardial Infarction (AMI)
Lead Sponsor:
John Paul II Hospital, Krakow
Collaborating Sponsors:
KCRI
National Center for Research and Development, Poland
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The main objective of the CIRCULATE project is to compare the clinical outcomes of CardioCell administration in treatment of ischemic damages of cardiovascular system with control group, who will be t...
Detailed Description
It is planned to enroll 105 patients into AMI trial with randomization into active (CardioCell) therapy and sham procedure/placebo administration with 2:1 ratio. Additional 5-10 subjects meeting incl...
Eligibility Criteria
Inclusion
- Acute myocardial infarction successfully treated by infarct related artery (IRA) successful revascularization
- Male and female patients, aged 18-80 years
- Large myocardial injury as demonstrated by LVEF ≤45% and/or infarct size (IS) ≥10% of the LV muscle on cMRI 2-5 days after pPCI
- Signed informed consent
Exclusion
- Pacemaker or other contraindications to cardiac MRI
- Malignancy
- Moderate or severe immunodeficiency
- Acute or chronic bacterial or viral infectious disease
- Soft tissue disease or local infection in a place of required artery puncture
- Pregnancy or breastfeeding
- Any objective or subjective reason for inability to attend follow-up visits
- Females of childbearing potential, who does not want to use a highly effective method of contraception
- Females of childbearing potential who does not have a menstrual period confirmed and a negative highly sensitive urine or serum pregnancy test
- Participation in any other clinical research study that has not reached the primary efficacy endpoint or otherwise would interfere with the patient's participation in this project
- Life expectancy \< 1 year
- Any concurrent disease or condition that, in the opinion of the investigator, would make the patient unsuitable for participation in the project
Key Trial Info
Start Date :
October 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT03404063
Start Date
October 20 2017
End Date
March 31 2021
Last Update
April 9 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
The John Paul II Hospital
Krakow, Poland, 31-202
2
Central Clinical Hospital of the MSWiA in Warsaw
Warsaw, Poland, 02-507