Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Intracoronary Injection of Autologous BMMC for LV Contractility and Remodeling in Patients With STEMI (RACE-STEMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02323620
Recruitment Status : Not yet recruiting
First Posted : December 23, 2014
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Pawel Buszman, American Heart of Poland

Brief Summary:
This is multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a triple intracoronary infusion of autologous bone marrow-derived mononuclear cells in addition to state of the art treatment is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction (≤45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.

Condition or disease Intervention/treatment Phase
Heart Failure Myocardial Infarction Procedure: Intracoronary infusion of BM-MC Phase 3

Detailed Description:

The study is divided into 3 parts:

  • Screening phase: Patients will be recruited at the investigational clinical centers. Alternatively, patients who had primary PCI performed at institutions different from the investigational sites can also be enrolled. Interested patients may be referred for screening to any of the participating study sites after acute reperfusion therapy. Informed consent and assessment of eligibility of patients with respect to in- and exclusion criteria will be done at the investigational site. If all other eligibility criteria are met, echocardiography will be performed 3 to 6 days after the acute PCI, and ejection fraction will be quantified by a central Echo Core Lab after web based transmission. CT examination will be performed 1 month after acute PCI in all screened patients with LVEF ≤ 45%. If LVEF will not improve ≥5% in the CT the patient may be qualified into the Study.
  • Treatment phase: Bone marrow aspiration will be performed for the patients assigned to the treatment group (II). Bone marrow will be collected from the patient and MNC isolated using point-of-care system (Harvest) at a Site. Intracoronary infusion of BM-MNCs will be performed up to 2 hours after isolation via radial approach. Same procedure will be performed 3 and 6 months after first application.
  • Follow-up phase: After hospital discharge, patients will be followed up per telephone 30 days and 3, 6, 9 months after randomisation and with a site visit with CT examination 12 months after randomisation. Afterwards, telephone follow up will be performed every 3 months. Once the required number of clinical events has been observed, all patients will attend a final study visit, but minimum follow up period for each patient is 2 years. Endpoints will be reported as occurring throughout the follow up.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Repeated Intracoronary Injection of Autologous Bone-marrow Derived Mononuclear Cells for Left Ventricle Contractility and Remodeling in Patients With STEMI.Prospective Randomized Study.
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
No Intervention: Standard care
Optimal standard care after myocardial infarction.
Experimental: Intracoronary infusion of BM-MC
Bone marrow-derived progenitor autologous cells aspiration and intracoronary infusion of the cells.
Procedure: Intracoronary infusion of BM-MC
Bone marrow-derived progenitor cells are obtained from 60ml bone marrow aspirated from the iliac crest. Intracoronary infusion of the autologous cells is performed via conventional percutaneous intracoronary intervention techniques using an over-the-wire balloon technique.




Primary Outcome Measures :
  1. Left ventricle ejection fraction change evaluated by CT [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Change in left ventricle End-Systolic Volume (ESV) and End-Diastolic Volume (EDV) evaluated by CT [ Time Frame: 12 months ]
  2. Time from randomisation to cardiac death [ Time Frame: 3 years ]
  3. Time from randomisation to cardiovascular death or rehospitalisation due to heart failure [ Time Frame: 3 years ]
  4. Incidence and severity of adverse events [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women of any ethnic origin aged ≥ 18 years.
  2. Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI.
  3. Successful acute reperfusion therapy (residual stenosis visually <50% and TIMI flow ≥2) within 24 hours of symptom onset or thrombolysis within 12 hours of symptom onset followed by successful percutaneous coronary intervention (PCI) within 24 hours after thrombolysis.
  4. Left ventricular ejection fraction ≤ 45% with significant regional wall motion abnormality assessed by quantitative echocardiography (central, independent core lab analysis) 3 to 6 days after reperfusion therapy
  5. Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion
  6. LVEF≤45% with significant regional wall motion abnormality assessed by computed tomography (CT) 30 days after reperfusion therapy with no LVEF improvement ≥5%.

Exclusion Criteria:

  1. Participation in another clinical trial within 30 days prior to randomisation
  2. Previously received stem/progenitor cell therapy
  3. Pregnant or nursing women
  4. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
  5. Necessity to revascularise additional vessels, outside the target coronary artery at the time of BM-MNC infusion (additional revascularisations after primary PCI and before BM-MNC cell infusion are allowed)
  6. Cardiogenic shock requiring mechanical support
  7. Platelet count <100,000/μl, or hemoglobin <8.5 g/dl
  8. Impaired renal function, i.e. serum creatinine >2.5 mg/dl
  9. Persistent fever or diarrhea not responsive to treatment within 4 weeks prior screening
  10. Clinically significant bleeding within 3 months prior screening
  11. Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)
  12. Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323620


Contacts
Layout table for location contacts
Contact: Pawel E. Buszman, MD, PhD, (+48) 607358348 pbuszman@ka.onet.pl
Contact: Stanislaw A. Trznadel, MD (+48) 502035700 strznadel@vp.pl

Locations
Layout table for location information
Poland
Polsko-Amerykańskie Kliniki Serca
Ustroń, Poland, 43-450
Contact: Pawel E Buszman, MD, PhD    (+48) 607358348    pbuszman@ka.onet.pl   
Contact: Stanislaw A Trznadel, MD    (+48) 502035700      
Sponsors and Collaborators
American Heart of Poland
Investigators
Layout table for investigator information
Principal Investigator: Pawel E Buszman, MD, PhD American Heart of Poland
Layout table for additonal information
Responsible Party: Pawel Buszman, MD, PhD, American Heart of Poland
ClinicalTrials.gov Identifier: NCT02323620    
Other Study ID Numbers: AHP-001
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: December 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pawel Buszman, American Heart of Poland:
Acute myocardial Infarction
bone marrow
stem cells
cardiovascular disease
mortality
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases