- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00350766
Cell Therapy in Myocardial Infarction (EMRTCC)
Multicenter Prospective Randomized Double Blind Trial of Bone Marrow Mononuclear Cells Transplantation Through Intracoronary Injection in Patients With Acute Myocardial Infarction.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study protocol describes a randomized double blind clinical trial, which main purpose is to evaluate the effect of the autologous bone marrow mononuclear cell (ABMMC) implant in 300 Brazilian patients with ST elevation acute myocardial infarction (STEMI).
Double blind study design was chosen for this trial, based on several phase I and II safety trials of intracoronary autologous bone marrow stem cells transplantation, already published. The study coordinator committee, supported by the Brazilian Health Ministry, therefore has proposed a phase III trial with the purpose of proving the efficacy of this kind of therapy, for a population with a high risk of developing heart failure and of death by cardiovascular cause.
Thus, in this protocol we propose a prospective, double blind, controlled and randomized trial to evaluate the effect of ABMMC transplantation through intracoronary infusion, on systolic left ventricle (LV) function. The main hypothesis of this trial is that patients submitted to autologous bone marrow stem cell implant, after 6 months follow up, will present a 5% relative increase of the ejection fraction (EF) comparing to control group.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Rio de Janeiro, Brazil, 22280-000
- PROCEP/Hospital Pró-Cardíaco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients will be eligible if presenting all characteristics described below:
ST segment elevation myocardial infarction in two or more contiguous leads, and according to the WHO definition, at least one of the following two:
i) Presence of chest pain. ii) Elevation of the myonecrosis markers.
- Age between 30 and 80 years old.
- Ejection fraction ≤50% on Echocardiogram (Simpson) and segmentary dysfunction of the infarction area, measured between the 3rd and 5th day post AMI.
Among patients submitted to thrombolytic therapy, the angioplasty of the related artery should be preferably done up to 24h after thrombolysis, with a maximum deadline of 72h after thrombolysis.
Exclusion Criteria:
Patients will be ineligible if presenting any of the characteristics described below:
- AMI related artery presenting TIMI < 3 at the moment f cell injection.
- Left Main Coronary Artery Lesion of >50% or multivessel coronariopathy (>70% lesion in vessels with >2,0mm diameter in left anterior descending, circumflex and right coronary territory) indicating the need for CABG or angioplasty with three or more stents implant.
- Coronary anatomy, after thrombolytic reperfusion, presenting no need for angioplasty with stent implant.
- Final Diastolic Pression of the LV higher than 30 mmHg during ventriculography for evaluating EF inclusion criteria for the research protocol (item "c" of inclusion criteria).
- Cardiac arrest or Killip IV AMI at admission with need of ventilatory support.
- Cardiogenic shock persisting up to the third day after AMI (with need of Intra-aortic balloon pump or vasopressors).
- AMI mechanical complications (ventricular septal defect, papillary muscle rupture, and left ventricular free wall rupture).
- Significant valve disease, defined as aortic stenosis (mean systolic pressure gradient across the aortic valve >50mmHg), mitral stenosis with a valvar area less than 1,5 cm,2 moderate to severe aortic and/or mitral regurgitation.
- Chronic use of immunosuppressive agents.
- > 2,0 mg/dl creatinine or previous dialysis treatment.
- Presence of fever on the past 48h before injection glaring active systemic infection according to ACCP/SCCM (American College of Chest Physicians/Society of Critical Care Medicine) sepsis definition.
- Sustained ventricular tachycardia 48h after AMI.
- Illicit drugs abuse or alcohol abuse (based on DSM IV).
- Any co morbidity, with survival impact in two years.
- Myocarditis
- Active liver disease
- COPD in continuous steroids use.
- Hematological disease, neoplasm, bone disease or hemostatic disturbances.
- Inflammatory disease or chronicle infectious disease.
- Presence of definitive implantation of a cardiac pace maker or cardiac defibrillator.
- Impossibility to reach a cells suspension of 100 million mononuclear cells due to cells paucity in the bone marrow aspirate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treated Group
Intracoronary injection in the infarcted-related artery of 100 million bone marrow mononuclear cells resuspended in a 10 ml solution of saline with autologous serum.
|
Catheter based stem cells delivery of 100 million cells resuspended in a 10 ml solution of saline with autologous serum.
About 100 ml of Bone Marrow aspirate were harvested from iliac crest between the fifth and seventh day after myocardial infarction.
ABMMC were isolated by density gradient centrifugation on Ficoll-PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions for injection, after being filtered through 100 um nylon mesh to remove cell aggregates.
Other Names:
|
Placebo Comparator: Control Group
Intracoronary injection in the infarcted-related artery of placebo solution consisting of a saline containing autologous blood serum.
|
Catheter based stem cells delivery of 100 million cells resuspended in a 10 ml solution of saline with autologous serum.
About 100 ml of Bone Marrow aspirate were harvested from iliac crest between the fifth and seventh day after myocardial infarction.
ABMMC were isolated by density gradient centrifugation on Ficoll-PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions for injection, after being filtered through 100 um nylon mesh to remove cell aggregates.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Global Left Ventricular Ejection Fraction change
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Death
Time Frame: 30 days, 90 days, 6 months and 1 year
|
30 days, 90 days, 6 months and 1 year
|
Acute myocardial infarction, stroke and hospital admission due to cardiovascular cause
Time Frame: 30 days, 90 days, 6 months and 1 year
|
30 days, 90 days, 6 months and 1 year
|
Reintervention of the AMI related artery and of the non-related artery
Time Frame: 30 days, 90 days, 6 months and 1 year
|
30 days, 90 days, 6 months and 1 year
|
Regional wall motion, wall thickening, and volume of late contrast enhancement
Time Frame: Baseline and 6 months
|
Baseline and 6 months
|
Evolutive alterations of the coronarian anatomy, as well as the patency of the coronary stents
Time Frame: 6 months
|
6 months
|
Quality of life assessment using the Short-Form 36, Minnesota Living with Heart Failure Questionnaire and Seattle Angina questionnaire
Time Frame: Baseline, 6 months and 1 year
|
Baseline, 6 months and 1 year
|
Cost-effectiveness and cost-utility evaluation of autologous bone marrow mononuclear cells implant versus conventional treatment
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Hans F Dohmann, MD, PROCEP/Pró-Cardíaco Hospital
Publications and helpful links
General Publications
- Tura BR, Martino HF, Gowdak LH, dos Santos RR, Dohmann HF, Krieger JE, Feitosa G, Vilas-Boas F, Oliveira SA, Silva SA, Bozza AZ, Borojevic R, de Carvalho AC. Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study. Trials. 2007 Jan 18;8:2. doi: 10.1186/1745-6215-8-2.
- Dohmann HF, Silva SA, Sousa AL, Braga AM, Branco RV, Haddad AF, Oliveira MA, Moreira RC, Tuche FA, Peixoto CM, Tura BR, Borojevic R, Ribeiro JP, Nicolau JC, Nobrega AC, Carvalho AC. Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction - MiHeart/AMI study. Trials. 2008 Jul 3;9:41. doi: 10.1186/1745-6215-9-41.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMRTCC-IAM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Myocardial Infarction
-
Henry Ford Health SystemAbiomed Inc.Enrolling by invitationAcute Myocardial Infarction | Cardiogenic Shock | STEMI | NSTEMI - Non-ST Segment Elevation MI | STEMI - ST Elevation Myocardial Infarction | NSTEMI | Acute Myocardial Infarction With ST Elevation | Acute Myocardial Infarction of Right Ventricle (Disorder) | Acute Myocardial Infarction of Left VentricleUnited States
-
Jordan Collaborating Cardiology GroupCardiovascular Academy GroupTerminatedTriggers of Acute Myocardial Infarction | Time of Onset of Acute Myocardial Infarction | Long-term Prognosis After Acute Myocardial InfarctionJordan
-
Recardio, Inc.CompletedAcute Myocardial Infarction | STEMI - ST Elevation Myocardial Infarction | Acute Myocardial IschemiaNetherlands, Hungary, Austria, Poland, Belgium
-
Medical Center of South ArkansasWithdrawnAcute Coronary Syndrome | Acute ST Segment Elevation Myocardial InfarctionUnited States
-
Yuan's General HospitalKaohsiung Veterans General Hospital.; Sin-Lau HospitalUnknownAcute Myocardial Infarction, of Inferolateral Wall | Acute Myocardial Infarction, of Inferoposterior WallTaiwan
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Acute Coronary Syndrome | Acute Myocardial Infarction | Metabolic DisturbanceGreece
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
Sheba Medical CenterCompletedNon ST Elevation Myocardial Infarction | Acute Coronary SyndromesIsrael
-
Medstar Health Research InstituteWithdrawnST-elevation Myocardial Infarction | Acute Myocardial InfarctionUnited States
-
Hennepin Healthcare Research InstituteSiemens HealthineersActive, not recruitingAcute Coronary Syndrome | Acute Myocardial InfarctionUnited States
Clinical Trials on Autologous Bone Marrow Mononuclear Cells (ABMMC) Transplantation
-
Xijing HospitalUnknownMyocardial InfarctionChina
-
TotipotentSC Scientific Product Pvt. Ltd.Thermogenesis Corp.CompletedCritical Limb IschemiaIndia
-
Da Nang HospitalTranslational Research Center for Medical Innovation, Kobe, Hyogo, Japan; Kitano...UnknownSpinal Cord InjuriesVietnam
-
Andalusian Network for Design and Translation of...Carlos III Health InstituteCompletedDiabetic Foot | Peripheral Vascular DiseasesSpain
-
Vinmec Healthcare SystemCompleted
-
The University of Texas Health Science Center,...Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedIschemic StrokeUnited States
-
Hebei Medical UniversityUnknownDiabetes | Lower Limb IschemiaChina
-
Chinese PLA General HospitalUnknownLeft Ventricular Dysfunction | Chronic Myocardial Ischemia | Old Myocardial InfarctionChina