Cell Therapy in Severe Chronic Ischemic Heart Disease (MiHeart)

August 28, 2019 updated by: Luis Henrique W Gowdak, MD, PhD, Ministry of Health, Brazil

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Intramyocardial Injection of Autologous Bone-Marrow Cells in Patients With Severe, Chronic Ischemic Heart Disease Undergoing Coronary Bypass Surgery

Patients with advanced coronary artery disease usually undergo incomplete myocardial revascularization due to the extension and diffuseness of the disease, with very poor distal arterial beds unsuitable for direct revascularization.

This study was designed to test the hypothesis that direct, intramyocardial injection of autologous bone marrow cells may further improve myocardial perfusion in patients undergoing incomplete bypass surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All eligible patients will undergo coronary artery bypass grafting (CABG) and, in previously identified areas of viable, ischemic myocardium unsuitable for direct revascularization, be randomized to either placebo (saline) or intramyocardial injection of bone marrow-derived cells (BMC) during surgery.

During follow-up, myocardial perfusion assessment will be performed to determine the improvement in treated areas compared to non-treated segments.

Study Type

Interventional

Enrollment (Actual)

143

Phase

  • 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

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-000
        • Heart Institute

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

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • symptoms of angina or angina equivalent
  • documented coronary artery disease (invasive angiography)
  • documented myocardial ischemia (stress echo, cardiac scintigraphy, or MRI)
  • unsuitable for complete myocardial revascularization (PCI or CABG) OR even if a complete procedure in feasible, it is anticipated that myocardial perfusion may not be restored due to poor distal beds

Exclusion Criteria:

  • severe LV dysfunction (EF < 25% on echo)
  • short life expectacy (below < 1 year)
  • diagnosis of cancer in the past 5 years
  • diagnosis of hematological diseases
  • diagnosis of severe heart disease of other etiologies including valvular heart disease, Chagas' disease, etc)
  • diagnosis of acute coronary syndrome in the past 3 months
  • diagnosis of chronic kidney disease stage V requiring chronic dialysis

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cell Therapy
Intramyocardial injection of autologous bone marrow-derived cells
Procedure: Cell Therapy
Intramyocardial injection of autologous bone marrow-derived cells
No Intervention: Placebo
Saline injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Increase in myocardial perfusion
Time Frame: 1, 6 and 12 months
Patients will undergo myocardial perfusion assessment by MRI during pharmacological stress with adenosine or dipyridamole. Alternatively, cardiac scintigraphy can be used in patients with contra-indications to MRI.
1, 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in LV function
Time Frame: 1, 6 and 12 months
LV function (global and regional) will be assessed by MRI.
1, 6 and 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in angina functional class
Time Frame: 1, 6 and 12 months
Angina functional class will be determined using the Canadian Cardiovascular Society classification.
1, 6 and 12 months

Collaborators and Investigators

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

Sponsor

Ministry of Health, Brazil

Investigators

  • Study Director: Jose Eduardo Krieger, MD, PhD, Heart Institute
  • Study Chair: Carlos Eduardo Rochitte, MD, PhD, Heart Institute

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.

General Publications

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)

January 1, 2006

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (Estimate)

November 15, 2012

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMRTCC-ISQ2

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.

Subscribe