Status:
TERMINATED
Cell Therapy in Myocardial Infarction
Lead Sponsor:
Ministry of Health, Brazil
Collaborating Sponsors:
Pro-Cardiaco Hospital
Hospital do Coracao
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
30-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction (STEMI)
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2014
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT00350766
Start Date
July 1 2006
End Date
July 14 2014
Last Update
March 30 2017
Active Locations (1)
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1
PROCEP/Hospital Pró-Cardíaco
Rio de Janeiro, Rio de Janeiro, Brazil, 22280-000