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

Primary Purpose

Heart Failure, Myocardial Infarction

Status

Unknown status

Phase

Phase 3

Locations

Poland

Study Type

Interventional

Intervention

Intracoronary infusion of BM-MC

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Acute myocardial Infarction, bone marrow, stem cells, cardiovascular disease, mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women of any ethnic origin aged ≥ 18 years.
Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI.
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.
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
Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion
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:

Participation in another clinical trial within 30 days prior to randomisation
Previously received stem/progenitor cell therapy
Pregnant or nursing women
Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol
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)
Cardiogenic shock requiring mechanical support
Platelet count <100,000/μl, or hemoglobin <8.5 g/dl
Impaired renal function, i.e. serum creatinine >2.5 mg/dl
Persistent fever or diarrhea not responsive to treatment within 4 weeks prior screening
Clinically significant bleeding within 3 months prior screening
Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg)
Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease

Sites / Locations

Polsko-Amerykańskie Kliniki Serca

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care

Intracoronary infusion of BM-MC

Arm Description

Optimal standard care after myocardial infarction.

Bone marrow-derived progenitor autologous cells aspiration and intracoronary infusion of the cells.

Outcomes

Primary Outcome Measures

Left ventricle ejection fraction change evaluated by CT

Secondary Outcome Measures

Change in left ventricle End-Systolic Volume (ESV) and End-Diastolic Volume (EDV) evaluated by CT

Time from randomisation to cardiac death

Time from randomisation to cardiovascular death or rehospitalisation due to heart failure

Incidence and severity of adverse events

Full Information

NCT ID

NCT02323620

First Posted

December 18, 2014

Last Updated

January 20, 2019

Sponsor

American Heart of Poland

1. Study Identification

Unique Protocol Identification Number

NCT02323620

Brief Title

Impact of Intracoronary Injection of Autologous BMMC for LV Contractility and Remodeling in Patients With STEMI

Acronym

RACE-STEMI

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.

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 2019 (Anticipated)

Primary Completion Date

July 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

American Heart of Poland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Myocardial Infarction

Keywords

Acute myocardial Infarction, bone marrow, stem cells, cardiovascular disease, mortality

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard care

Arm Type

No Intervention

Arm Description

Optimal standard care after myocardial infarction.

Arm Title

Intracoronary infusion of BM-MC

Arm Type

Experimental

Arm Description

Bone marrow-derived progenitor autologous cells aspiration and intracoronary infusion of the cells.

Intervention Type

Procedure

Intervention Name(s)

Intracoronary infusion of BM-MC

Intervention Description

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 Measure Information:

Title

Left ventricle ejection fraction change evaluated by CT

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change in left ventricle End-Systolic Volume (ESV) and End-Diastolic Volume (EDV) evaluated by CT

Time Frame

12 months

Title

Time from randomisation to cardiac death

Time Frame

3 years

Title

Time from randomisation to cardiovascular death or rehospitalisation due to heart failure

Time Frame

3 years

Title

Incidence and severity of adverse events

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women of any ethnic origin aged ≥ 18 years. Patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI. 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. 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 Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion 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: Participation in another clinical trial within 30 days prior to randomisation Previously received stem/progenitor cell therapy Pregnant or nursing women Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study or to follow the protocol 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) Cardiogenic shock requiring mechanical support Platelet count <100,000/μl, or hemoglobin <8.5 g/dl Impaired renal function, i.e. serum creatinine >2.5 mg/dl Persistent fever or diarrhea not responsive to treatment within 4 weeks prior screening Clinically significant bleeding within 3 months prior screening Uncontrolled hypertension (systolic >180 mmHg and diastolic >120 mmHg) Life expectancy of less than 2 years from any non-cardiac cause or neoplastic disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pawel E. Buszman, MD, PhD,

Phone

(+48) 607358348

pbuszman@ka.onet.pl

First Name & Middle Initial & Last Name or Official Title & Degree

Stanislaw A. Trznadel, MD

Phone

(+48) 502035700

strznadel@vp.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pawel E Buszman, MD, PhD

Organizational Affiliation

American Heart of Poland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Polsko-Amerykańskie Kliniki Serca

City

Ustroń

ZIP/Postal Code

43-450

Country

Poland

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pawel E Buszman, MD, PhD

Phone

(+48) 607358348

pbuszman@ka.onet.pl

First Name & Middle Initial & Last Name & Degree

Stanislaw A Trznadel, MD

Phone

(+48) 502035700

12. IPD Sharing Statement

Learn more about this trial

Impact of Intracoronary Injection of Autologous BMMC for LV Contractility and Remodeling in Patients With STEMI

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