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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cell Therapy | Experimental | Intramyocardial injection of autologous bone marrow-derived cells |
|
| Placebo | No Intervention | Saline injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell Therapy | Procedure | Intramyocardial injection of autologous bone marrow-derived cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Increase in myocardial perfusion | 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. | 1, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in LV function | LV function (global and regional) will be assessed by MRI. | 1, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in angina functional class | Angina functional class will be determined using the Canadian Cardiovascular Society classification. | 1, 6 and 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Eduardo Krieger, MD, PhD | Heart Institute | Study Director |
| Carlos Eduardo Rochitte, MD, PhD | Heart Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute | São Paulo | São Paulo | 05403-000 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17233910 | Background | 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. doi: 10.1186/1745-6215-8-2. | |
| 36824456 | Derived |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D064987 | Cell- and Tissue-Based Therapy |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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Intramyocardial injection of bone marrow-derived cells OR placebo (saline) during CABG
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| Gowdak LHW, Schettert IT, Rochitte CE, de Carvalho LP, Vieira MLC, Dallan LAO, de Oliveira SA, Cesar LAM, Brito JOR, Guarita-Souza LC, de Carvalho ACC, Krieger JE. Additional improvement in regional myocardial ischemia after intracardiac injection of bone marrow cells during CABG surgery. Front Cardiovasc Med. 2023 Feb 7;10:1040188. doi: 10.3389/fcvm.2023.1040188. eCollection 2023. |
| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |