Cardiovascular Clinical Project to Evaluate the Regenerative Capacity of CardioCell in Patients With Acute Myocardial Infarction (AMI)
- Conditions
- Myocardial Infarction
- Interventions
- Drug: PlacebosDrug: Cardiac Drug
- Registration Number
- NCT03404063
- Lead Sponsor
- John Paul II Hospital, Krakow
- 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 treated by the administration of placebo during the sham procedure.
- 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 inclusion/exclusion criteria will receive, in a non-blinded fashion, labelled CardioCell to determine the early uptake and retention of IMP in the target ischemic tissues.
The primary research question of this project is to check if the administration of CardioCell could improve the clinical outcomes in patients with AMI. There are several secondary questions, defined by secondary endpoints, e.g.: if the investigated treatment is possible to administered, if the investigated treatment is safe and way of CardioCell administration, if it is possible to define any selected subgroup in which the treatment results are significantly different than in whole group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group Placebos Patients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner. Active Group Cardiac Drug Patients randomized to the active treatment group will receive 30 000 000 WJMSCs suspended in 20mL 0.9% NaCl and 5% albumin administered via the IRA.
- Primary Outcome Measures
Name Time Method Reduction of infarct size Index hospitalization and in 6 month FU Reduction of infarct size assessed in cardiac MRI during index hospitalization and in 6 month FU between two groups (active vs sham).
- Secondary Outcome Measures
Name Time Method Myocardial perfusion improvement 6 month FU Myocardial perfusion improvement assessed in cardiac MRI.
Infarct size reduction 6 month FU Infarct size reduction in SPECT.
Increase of left ventricle ejection fraction (LVEF) 6 month FU Increase of left ventricle ejection fraction (LVEF) assessed in SPECT.
Left ventricle ejection fraction (LVEF) change against baseline. 6 month FU Left ventricle ejection fraction (LVEF) change (in %) against baseline, assessed in echocardiography.
Left ventricle end-systolic volume (ESV) change against baseline. 6 month FU Left ventricle end-systolic volume (ESV, in ml) change against baseline, assessed in echocardiography
Left ventricle end-diastolic volume (EDV) change against baseline. 6 month FU Left ventricle end-diastolic volume (EDV, in ml) change against baseline, assessed in echocardiography.
The occurrence of major adverse cardiovascular events 1 year FU The occurrence of major adverse cardiovascular events (MACE including death, myocardial infarction, and hospitalization for heart failure).
Quality of life improvement 6 month and 1 year FU. Quality of life improvement, assessed by SF-36 questionnaire or other dedicated for investigated population.
Trial Locations
- Locations (2)
Central Clinical Hospital of the MSWiA in Warsaw
🇵🇱Warsaw, Poland
The John Paul II Hospital
🇵🇱Cracovia, Poland