Cell Therapy in Severe Chronic Ischemic Heart Disease (MiHeart)
Recruitment status was: Recruiting
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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 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 |
- 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.
- Improvement in LV function [ Time Frame: 1, 6 and 12 months ]LV function (global and regional) will be assessed by MRI.
- Improvement in angina functional class [ Time Frame: 1, 6 and 12 months ]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
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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
Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01727063
| 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 |
| Brazil | |
| Heart Institute | Recruiting |
| Sao Paulo, SP, Brazil, 05403-000 | |
| Principal Investigator: Luis Henrique W Gowdak, MD, PhD | |
| 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 |
| First Submitted: | November 12, 2012 |
| 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 |