Cell Therapy in Severe Chronic Ischemic Heart Disease (MiHeart)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2012 by Ministry of Health, Brazil.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Dr. Luís Henrique W. Gowdak, Ministry of Health, Brazil

ClinicalTrials.gov Identifier:

NCT01727063

First received: November 12, 2012

Last updated: NA

Last verified: November 2012

History: No changes posted

Purpose

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	Intervention	Phase
Chronic Ischemic Heart Disease Coronary Artery Disease Angina Pectoris	Procedure: Cell Therapy	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Disease Heart Diseases

U.S. FDA Resources

Further study details as provided by Ministry of Health, Brazil:

Primary Outcome Measures:

Increase in myocardial perfusion [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]
LV function (global and regional) will be assessed by MRI.

Other Outcome Measures:

Improvement in angina functional class [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]
Angina functional class will be determined using the Canadian Cardiovascular Society classification.


Estimated Enrollment:	200
Study Start Date:	January 2006
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727063

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

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
Study First Received:	November 12, 2012
Last Updated:	November 12, 2012
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by 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 Ischemia 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

ClinicalTrials.gov processed this record on September 29, 2016

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