Cell Therapy in Severe Chronic Ischemic Heart Disease (MiHeart)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01727063
Recruitment Status : Unknown
Verified November 2012 by Dr. Luís Henrique W. Gowdak, Ministry of Health, Brazil.
Recruitment status was:  Recruiting
First Posted : November 15, 2012
Last Update Posted : November 15, 2012
Information provided by (Responsible Party):
Dr. Luís Henrique W. Gowdak, Ministry of Health, Brazil

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.

Condition or disease Intervention/treatment Phase
Chronic Ischemic Heart Disease Coronary Artery Disease Angina Pectoris Procedure: Cell Therapy Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2006
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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.

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01727063

Contact: Meyrielli A Vieira +55-11-2661-5000 ext 5377
Contact: Luis Henrique Gowdak, MD, PhD +55-11-2661-5000 ext 5929

Heart Institute Recruiting
Sao Paulo, SP, Brazil, 05403-000
Principal Investigator: Luis Henrique W Gowdak, MD, PhD         
Sponsors and Collaborators
Ministry of Health, Brazil
Study Director: Jose Eduardo Krieger, MD, PhD Heart Institute
Study Chair: Carlos Eduardo Rochitte, MD, PhD Heart Institute

Responsible Party: Dr. Luís Henrique W. Gowdak, Clinical Coordinator, Ministry of Health, Brazil Identifier: NCT01727063     History of Changes
Other Study ID Numbers: EMRTCC-ISQ2
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: November 15, 2012
Last Verified: November 2012

Keywords provided by Dr. Luís Henrique W. Gowdak, Ministry of Health, Brazil:
Chronic ischemic heart disease
Coronary artery disease
Angina pectoris
Myocardial ischemia
Cardiac surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Angina Pectoris
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms