Heart FailurePhase 3RACE-STEMINCT02323620
Impact of Intracoronary Injection of Autologous BMMC for LV Contractility and Remodeling in Patients With STEMI
A Phase 3 study testing Intracoronary infusion of BM-MC in people with Heart Failure and Myocardial Infarction, run by American Heart of Poland at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Myocardial Infarction
- What is being tested?
- Intracoronary infusion of BM-MC
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- Mar 2019to Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Polsko-Amerykańskie Kliniki Serca
Ustroń, 43-450
Pawel E Buszman, MD, PhD, (+48) 607358348, pbuszman@ka.onet.pl
Stanislaw A Trznadel, MD, (+48) 502035700
About this study
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.
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.
Read the 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.
- Conditions
- Heart Failure, Myocardial Infarction
- Being tested
- Intracoronary infusion of BM-MC
- Keywords
- Acute myocardial Infarction, bone marrow, stem cells, cardiovascular disease, mortality
- Medical subject headings
- Heart Failure, Myocardial Infarction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracoronary infusion of BM-MCProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Optimal standard care after myocardial infarction. |
| Intracoronary infusion of BM-MC | Experimental | Bone marrow-derived progenitor autologous cells aspiration and intracoronary infusion of the cells. Receives: Procedure: Intracoronary infusion of BM-MC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricle ejection fraction change evaluated by CT
Measured: 12 months
Secondary outcomes (4)
Change in left ventricle End-Systolic Volume (ESV) and End-Diastolic Volume (EDV) evaluated by CT
Measured: 12 months
Time from randomisation to cardiac death
Measured: 3 years
Time from randomisation to cardiovascular death or rehospitalisation due to heart failure
Measured: 3 years
Incidence and severity of adverse events
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study startMar 2019 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Heart of Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawel Buszman, American Heart of Poland
- Investigators
- Pawel E Buszman, MD, PhD, Principal investigator, American Heart of Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323620
- Sponsor's protocol ID
- AHP-001
- Acronym
- RACE-STEMI
- Status last verified
- Dec 2018
- First submitted
- 18 Dec 2014
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02323620
- Acronym / sponsor ID
- RACE-STEMI / AHP-001
- Conditions
- Heart Failure, Myocardial Infarction
- Keywords
- Acute myocardial Infarction, bone marrow, stem cells, cardiovascular disease, mortality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- American Heart of PolandUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Optimal standard care after myocardial infarction. |
| Intracoronary infusion of BM-MC | Experimental | Procedure: Intracoronary infusion of BM-MCBone marrow-derived progenitor autologous cells aspiration and intracoronary infusion of the cells. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracoronary infusion of BM-MCBone 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. | Procedure or surgery | Intracoronary infusion of BM-MC |
Primary outcome
Left ventricle ejection fraction change evaluated by CT
Time frame: 12 months
4 secondary outcomes
Change in left ventricle End-Systolic Volume (ESV) and End-Diastolic Volume (EDV) evaluated by CT
Time frame: 12 months
Time from randomisation to cardiac death
Time frame: 3 years
Time from randomisation to cardiovascular death or rehospitalisation due to heart failure
Time frame: 3 years
Incidence and severity of adverse events
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pawel E Buszman, MD, PhD principal investigator
American Heart of Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intracoronary infusion of BM-MC in people with Heart Failure and Myocardial Infarction, run by American Heart of Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pawel E. Buszman, MD, PhD, ((+48) 607358348, pbuszman@ka.onet.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricle ejection fraction change evaluated by CT (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.