Clinical trial NCT01569178: BAMI. The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction
Official title: The Effect of Intracoronary Reinfusion of Bone Marrow-derived Mononuclear Cells(BM-MNC) on All Cause Mortality in Acute Myocardial Infarction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Death
Keywords: stem cells
acute myocardial infarction
heart failure
heart attack
bone marrow
intracoronary reinfusion
bone marrow derived mononuclear cells
Left ventricular function improvement
mortality
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2012-04-03
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multinational, multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a single intracoronary infusion of autologous bone marrow-derived mononuclear cells 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.


Eligibility criteria: Inclusion Criteria:

* signed and dated informed consent form
* men and women of any ethnic origin aged≥18years
* patients with acute ST-elevation myocardial infarction as defined by the universal definition of AMI (including new LBBB)
* 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) 2 to 6 days after reperfusion therapy
* Open coronary artery suitable for cell infusion supplying the target area of abnormal wall motion

Exclusion Criteria:

* Participation in another clinical trial within 30 days prior randomisation unless non interventional trials or trials where patients are randomised to only standard care and this has been discussed and agreed with the CI/sponsor prior to consenting
* 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 progenitor cell infusion (additional revascularisations after primary PCI and before BM-MNC cell infusion are allowed), unless clinically indicated and according to latest guidelines. This decision should be made at the time of the index procedure and explicitly stated at that time.
* Cardiogenic shock requiring mechanical support
* Platelet count \<100.000/µl, or hemoglobin \<8.5 g/dl
* Impaired renal function, i.e. creatinine \>2.5 mg/dl
* Fever or diarrhoea not responsive to treatment within 4 weeks prior screening
* Cliinically significant bleeding disorder within 3 months prior screening
* Uncontrolled hypertension (systolic \>180 mmHg and diastolic \>120 mmHg)
* Life expectancy of less than two years from any non-cardiac cause or uncontrolled neoplastic disease

Primary outcomes:
measure: Time from randomization to all-cause death
timeFrame: for an average of 3 years
Secondary outcomes:
measure: Time from randomization to cardiac death
timeFrame: for an average of 3 years
measure: time from randomization to cardiovascular rehospitalisation
timeFrame: for an average of 3 years
measure: incidence and severity of adverse events
timeFrame: for an average of 3 years
measure: bleeding by BARC definition
timeFrame: for an average of 3 years
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Cardiovascular Research Centre VZW
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
city: Brno
country: Czechia
facility: Fakultni Nemocnice BRNO
city: Copenhagen
country: Denmark
facility: Region Hovedstaden
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Bad Berka
country: Germany
facility: Zentralklinik Bad Berka
city: Berlin
country: Germany
facility: Universitätsmedizin Charité Berlin
city: Bonn
country: Germany
facility: UniLinikum Bonn
city: Dusseldorf
country: Germany
facility: Universtitatsklinikum Dusseldorf, Klinik fur Kardiologie, Pneumologie und Angiologie
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt GmbH
city: Essen
country: Germany
facility: University Hospital Essen
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe Universitaet Frankfurt AM MAIN
city: Fulda
country: Germany
facility: Klinikum Fulda gAG
city: Greifswald
country: Germany
facility: Universitatsmedizin Greifswald Klinik Und Poliklinik Innere Med
city: Lubeck
country: Germany
facility: UKSh Campus Lubeck, Med. Klinik II
city: Neustadt
country: Germany
facility: Krankenhaus Hetzelstift Neustadt
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl GmbH
city: Ulm
country: Germany
facility: University Hospital Ulm, Clinic of Internal Medicine II
city: Rome
country: Italy
facility: Universita Cattolica Del Sacro Cuore
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Clinico San Carlos
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
city: Madrid
country: Spain
facility: Servico Madrileno De Salud
city: Salamanca
country: Spain
facility: Hospital Clinico Salamanca
city: Santander
country: Spain
facility: H.U. Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario De Valladolid
city: Zaragoza
country: Spain
facility: Hospiatl Universitatio Miguel Servet
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: London
country: United Kingdom
facility: Queen Mary, University of London (QMUL)
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital, Royal Wolverhampton NHS Trust
Study officials:
affiliation: Queen Mary University of London
name: Anthony Mathur, MD, FRCP, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mathur A, Arnold R, Assmus B, Bartunek J, Belmans A, Bonig H, Crea F, Dimmeler S, Dowlut S, Fernandez-Aviles F, Galinanes M, Garcia-Dorado D, Hartikainen J, Hill J, Hogardt-Noll A, Homsy C, Janssens S, Kala P, Kastrup J, Martin J, Menasche P, Miklik R, Mozid A, San Roman JA, Sanz-Ruiz R, Tendera M, Wojakowski W, Yla-Herttuala S, Zeiher A. The effect of intracoronary infusion of bone marrow-derived mononuclear cells on all-cause mortality in acute myocardial infarction: rationale and design of the BAMI trial. Eur J Heart Fail. 2017 Nov;19(11):1545-1550. doi: 10.1002/ejhf.829. Epub 2017 Sep 25.