Heart Diseases, Myocardial Infarction
Conditions
Brief summary
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)
Interventions
DEVICEHeart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells
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)
Sponsors
Fakultas Kedokteran Universitas Indonesia
RSUPN dr. Cipto Mangunkusumo
Rumah Sakit Universitas Indonesia
Pusat Jantung Nasional Harapan Kita
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Aged 40 - 60 years old * Ischemic burden \>10% and ischemic gradients red-violet * Ischemic area is not feasible to be grafted (bypass) due to other conditions such as diffusion and deep intramuscular vascularization * Ejection fraction \>30-35% * Euro score \<8
Exclusion criteria
* Scanning of Technetium-99 showed black colored ischemic area * Patients undergoing other procedures other than bypass such as valve repair * Chronic kidney failure * Patients have went through several bypass surgeries prior * Patients are still COVID-19 positive * Immunocompromised patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of the ischemic burden (%) | Comparison from the imaging within 3 months before intervention, and after 6 months post treatment. | Diagnosed by MRI |
| Change in the regional heart wall motion abnormality | Observation of the heart wall motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention | measured using Echocardiographic |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of the electrocardiographic wave | Observation of electrocardiogram records by 1 week before intervention and 4 - 12 - 24 weeks after intervention | Measured using electrocardiogram |
| Change of the ejection fraction | Observation of the heart motion by 1 week before intervention and 4 - 12 - 24 weeks after intervention | Measured using echocardiography |
Countries
Indonesia
Contacts
Primary ContactNormalina Sandora, MD, PhD
Outcome results
None listed