Cell Therapy in Severe Chronic Ischemic Heart Disease (MiHeart)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Meyrielli A Vieira	+55-11-2661-5000 ext 5377	meyri.vieira@incor.usp.br
Contact: Luis Henrique Gowdak, MD, PhD	+55-11-2661-5000 ext 5929	luis.gowdak@incor.usp.br

Locations

Brazil
Heart Institute	Recruiting
Sao Paulo, SP, Brazil, 05403-000
Principal Investigator: Luis Henrique W Gowdak, MD, PhD

Sponsors and Collaborators

Ministry of Health, Brazil

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

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

Ischemia; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Angina Pectoris; Pathologic Processes; Cardiovascular Diseases	Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms