Cell Therapy in Myocardial Infarction (EMRTCC)

March 29, 2017 updated by: Hans Fernando Rocha Dohmann, Ministry of Health, Brazil

Multicenter Prospective Randomized Double Blind Trial of Bone Marrow Mononuclear Cells Transplantation Through Intracoronary Injection in Patients With Acute Myocardial Infarction.

The purpose of this study is to determine cell therapy efficacy in patients with ST elevation acute myocardial infarction (STEMI)

Study Overview

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

Interventional

Enrollment (Actual)

166

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rio de Janeiro, Brazil, 22280-000
        • PROCEP/Hospital Pró-Cardíaco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Catheter based stem cell delivery
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:
  • Catheter based stem cell delivery

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2006

Primary Completion (Actual)

January 21, 2014

Study Completion (Actual)

July 14, 2014

Study Registration Dates

First Submitted

July 10, 2006

First Submitted That Met QC Criteria

July 10, 2006

First Posted (Estimate)

July 11, 2006

Study Record Updates

Last Update Posted (Actual)

March 30, 2017

Last Update Submitted That Met QC Criteria

March 29, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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