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| Name | Class |
|---|---|
| Fakultas Kedokteran Universitas Indonesia | OTHER |
| RSUPN dr. Cipto Mangunkusumo | UNKNOWN |
| Rumah Sakit Universitas Indonesia | UNKNOWN |
| Pusat Jantung Nasional Harapan Kita |
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Myocardial infarction (MI), as one of the many complications of COVID-19, is one of the contributing patients of patients' death. This study attempts on developing an intervention of MI by regenerating damaged cardiomyocytes due to insufficiency of oxygen in cardiac muscles, triggered by an occlusion of coronary artery (MI). Heart patch developed from amnion bilayer seeded with amnion epithelial stem cells and patient's autologous cardiomyocytes is used as a therapy. Patients who undergo bypass (CABG) surgery are given heart patch, and then patients condition are observed by ECG, Echo, blood test, and radiology (technetium-99m)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heart patch + cardiomyocytes - hAESC | Experimental | Patients who undergo bypass (CABG) surgery are given heart patch in areas where grafting (bypass) is not feasible |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells | Device | heart patch is seeded with patient's cardiomyocytes (taken from patient's heart waste tissue when undergoing bypass surgery) and stock amnion epithelial stem cells (HLA-DR negative to eliminate risk of rejection) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the ischemic burden (%) | Diagnosed by MRI | Comparison from the imaging within 3 months before intervention, and after 6 months post treatment. |
| Change in the regional heart wall motion abnormality | measured using Echocardiographic | Observation of the heart wall motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change of the electrocardiographic wave | Measured using electrocardiogram | Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention |
| Change of the ejection fraction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Normalina Sandora, MD, PhD | Contact | +62 812-9896-3425 | normalinasandora@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RSUPN dr. Cipto Mangunkusumo | Recruiting | Jakarta | DKI Jakarta | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
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| UNKNOWN |
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|
Measured using echocardiography
| Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention |
| Rumah Sakit Universitas Indonesia | Not yet recruiting | Depok | West Java | 16424 | Indonesia |
|
| Pusat Jantung Nasional Harapan Kita | Not yet recruiting | Jakarta | 11420 | Indonesia |
|
| D007511 |
| Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |