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Cell Therapy in Myocardial Infarction (EMRTCC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2006 by Ministry of Health, Brazil.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Pro-Cardiaco Hospital
Hospital do Coracao
Instituto Estadual de Cardiologia Aloysio de Castro
Hospital Cardiológico Costantini
Hospital Universitario Pedro Ernesto
Hospital Universitário Regional do Norte do Paraná - FUEL
Hospital Santa Izabel da Bahia
Hospital Santa Izabel do Sergipe
Hospital Agamenon
Hospital do Andaraí
Hospital de Messejana
Hospital de Clinicas de Porto Alegre
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Instituto Nacional de Cardiologia de Laranjeiras
Instituto de Cardiologia do Rio Grande do Sul
Hospital São Marcos
Hospital Universitário Oswaldo Cruz - UPE
Real Hospital Português de Beneficência
Hospital Municipal Miguel Couto
Anis Rassi Hospital, Brazil
Federal University of São Paulo
Instituto Dante Pazzanese de Cardiologia
Universidade Federal do Rio de Janeiro
Hospital Bandeirantes
InCor Heart Institute
Information provided by:
Ministry of Health, Brazil
ClinicalTrials.gov Identifier:
NCT00350766
First received: July 10, 2006
Last updated: September 19, 2007
Last verified: August 2006
  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.

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Brazil:

Primary Outcome Measures:
  • Global Left Ventricular Ejection Fraction change [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00350766

Contacts
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

Locations
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         
Sponsors and Collaborators
Ministry of Health, Brazil
Pro-Cardiaco Hospital
Hospital do Coracao
Instituto Estadual de Cardiologia Aloysio de Castro
Hospital Cardiológico Costantini
Hospital Universitario Pedro Ernesto
Hospital Universitário Regional do Norte do Paraná - FUEL
Hospital Santa Izabel da Bahia
Hospital Santa Izabel do Sergipe
Hospital Agamenon
Hospital do Andaraí
Hospital de Messejana
Hospital de Clinicas de Porto Alegre
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto
Instituto Nacional de Cardiologia de Laranjeiras
Instituto de Cardiologia do Rio Grande do Sul
Hospital São Marcos
Hospital Universitário Oswaldo Cruz - UPE
Real Hospital Português de Beneficência
Hospital Municipal Miguel Couto
Anis Rassi Hospital, Brazil
Federal University of São Paulo
Instituto Dante Pazzanese de Cardiologia
Universidade Federal do Rio de Janeiro
Hospital Bandeirantes
InCor Heart Institute
Investigators
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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014