Cell Therapy in Myocardial Infarction (EMRTCC)
Recruitment status was Recruiting
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Purpose
The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction (STEMI)
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myocardial Infarction |
Procedure: Catheter based Stem cells delivery Other: Autologous Bone Marrow Mononuclear Cells Transplantation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Multicenter Prospective Randomized Double Blind Trial of Bone Marrow Mononuclear Cells Transplantation Through Intracoronary Injection in Patients With Acute Myocardial Infarction. |
- Global Left Ventricular Ejection Fraction change [ Time Frame: 6 months ]
- Death [ Time Frame: 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 ]
- Reintervention of the AMI related artery and of the non-related artery [ Time Frame: 30 days, 90 days, 6 months and 1 year ]
- Regional wall motion, wall thickening, and volume of late contrast enhancement [ Time Frame: 30 days, 90 days, 6 months and 1 year ]
- Evolutive alterations of the coronarian anatomy, as well as the patency of the coronary stents [ Time Frame: 6 months ]
- Quality of life assessment using the Short-Form 36, Minnesota Living with Heart Failure Questionnaire and Seattle Angina questionnaire [ Time Frame: 3 months, 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 ]
| Estimated Enrollment: | 300 |
| Study Start Date: | July 2006 |
| Estimated Study Completion Date: | July 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: I
Injection of 100 million bone marrow mononuclear cells resuspended in a 10 ml solution of saline with autologous serum
|
Procedure: Catheter based Stem cells delivery
About 100 ml of Bone Marrow aspirate will be harvested from iliac crest between the fifth and seventh day after myocardial reperfusion therapy. ABMMC will be isolated by density gradient centrifugation on Ficoll-PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions. A total of 100 million cells will be resuspended in a 10 ml solution of saline with autologous serum and filtered through 100 um nylon mesh to remove cell aggregates for injection.
Other: Autologous Bone Marrow Mononuclear Cells Transplantation
About 100 ml of Bone Marrow aspirate will be harvested from iliac crest between the fifth and seventh day after myocardial reperfusion therapy. ABMMC will be isolated by density gradient centrifugation on Ficoll- PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions. A total of 100 million cells will be resuspended in a 10 ml solution of saline with autologous serum and filtered through 100 um nylon mesh to remove cell aggregates for injection.
|
|
Placebo Comparator: II
Placebo consists of a saline solution containing autologous blood serum.
|
Procedure: Catheter based Stem cells delivery
About 100 ml of Bone Marrow aspirate will be harvested from iliac crest between the fifth and seventh day after myocardial reperfusion therapy. ABMMC will be isolated by density gradient centrifugation on Ficoll-PaqueTM plus (Amersham Biosciences) and manipulated under aseptic conditions. A total of 100 million cells will be resuspended in a 10 ml solution of saline with autologous serum and filtered through 100 um nylon mesh to remove cell aggregates for injection.
|
Detailed Description:
This study protocol describes a randomized double blind clinical trial, which main main purpose is to evaluate the effect of the autologous bone marrow stem cell 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 autologous bone marrow stem cells intracoronary implant, already published. The study coordinator committee, supported by the Health Ministry and the Science and Technology 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 autologous bone marrow stem cell transplantation through intracoronary infusion, regarding systolic 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 comparing to control group.
Eligibility| Ages Eligible for Study: | 30 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients will be eligible if presenting all characteristics described below:
ST segment elevation myocardial infarction, according to the WHO definition (two from the following three):
i) Presence of chest pain. ii) Presence of ST segment elevation in two or more contiguous leads. iii) Elevation of the myonecrosis markers.
- Age between 30 and 80 years old.
- Invasive ventriculography presenting ejection fraction <50% (Dodge method) and segmentary dysfunction of the infarction area, measured immediately before PCI. 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 48h after thrombolysis. This recommendation is based on the last Percutaneous Coronary Intervention guideline published by the European Society of Cardiology, in April 2005.68 IA recommendation degree.
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.
Contacts and Locations| Contact: Hans F Dohmann, MD | (5521) 2131-1508 | diretoria.cientifica@procardiaco.com.br |
| Contact: Suzana A Silva, MD | (5521) 2131-1508 | suzana.silva@procardiaco.com.br |
| Brazil | |
| PROCEP/Hospital Pró-Cardíaco | Recruiting |
| Rio de Janeiro, Brazil, 22280-000 | |
| Contact: Hans F Dohmann, MD (5521)3201-1508 diretoria.cientifica@procardiaco.com.br | |
| Principal Investigator: Hans F Dohmann, MD | |
| Principal Investigator: | Hans F Dohmann, MD | PROCEP/Pró-Cardíaco Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00350766 History of Changes |
| Other Study ID Numbers: | EMRTCC-IAM |
| Study First Received: | July 10, 2006 |
| Last Updated: | September 19, 2007 |
| Health Authority: | Brazil: Ministry of Health |
Keywords provided by Ministry of Health, Brazil:
|
Myocardial Infarction Myocardial Ischemia Ventricular Remodeling Bone Marrow Cell Transplantation Stem cells |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013