Cell Therapy in Severe Chronic Ischemic Heart Disease (MiHeart)

This study is currently recruiting participants.
Verified November 2012 by Ministry of Health, Brazil
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:


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
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
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:
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
Angina Pectoris
Heart Diseases
Ischemia
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014