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Cell Therapy in Severe Chronic Ischemic Heart Disease (MiHeart)

Primary Purpose

Chronic Ischemic Heart Disease, Coronary Artery Disease, Angina Pectoris

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Cell Therapy
Sponsored by
Ministry of Health, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Ischemic Heart Disease focused on measuring Chronic ischemic heart disease, Coronary artery disease, Angina pectoris, Myocardial ischemia, Cardiac surgery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cell Therapy

Placebo

Arm Description

Intramyocardial injection of autologous bone marrow-derived cells

Saline injection

Outcomes

Primary Outcome Measures

Increase in myocardial perfusion
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.

Secondary Outcome Measures

Improvement in LV function
LV function (global and regional) will be assessed by MRI.

Full Information

First Posted
November 12, 2012
Last Updated
August 28, 2019
Sponsor
Ministry of Health, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT01727063
Brief Title
Cell Therapy in Severe Chronic Ischemic Heart Disease
Acronym
MiHeart
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2006 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Brazil

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Ischemic Heart Disease, Coronary Artery Disease, Angina Pectoris
Keywords
Chronic ischemic heart disease, Coronary artery disease, Angina pectoris, Myocardial ischemia, Cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Intramyocardial injection of bone marrow-derived cells OR placebo (saline) during CABG
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cell Therapy
Arm Type
Experimental
Arm Description
Intramyocardial injection of autologous bone marrow-derived cells
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
Saline injection
Intervention Type
Procedure
Intervention Name(s)
Cell Therapy
Intervention Description
Intramyocardial injection of autologous bone marrow-derived cells
Primary Outcome Measure Information:
Title
Increase in myocardial perfusion
Description
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.
Time Frame
1, 6 and 12 months
Secondary Outcome Measure Information:
Title
Improvement in LV function
Description
LV function (global and regional) will be assessed by MRI.
Time Frame
1, 6 and 12 months
Other Pre-specified Outcome Measures:
Title
Improvement in angina functional class
Description
Angina functional class will be determined using the Canadian Cardiovascular Society classification.
Time Frame
1, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Eduardo Krieger, MD, PhD
Organizational Affiliation
Heart Institute
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Carlos Eduardo Rochitte, MD, PhD
Organizational Affiliation
Heart Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Heart Institute
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
17233910
Citation
Tura BR, Martino HF, Gowdak LH, dos Santos RR, Dohmann HF, Krieger JE, Feitosa G, Vilas-Boas F, Oliveira SA, Silva SA, Bozza AZ, Borojevic R, de Carvalho AC. Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study. Trials. 2007 Jan 18;8:2. doi: 10.1186/1745-6215-8-2.
Results Reference
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Cell Therapy in Severe Chronic Ischemic Heart Disease

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