Heart Patch for Myocardial Infarction COVID-19

Not Applicable

• Conditions: Myocardial Infarction; Heart Diseases
• Interventions: Device: Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells

• Registration Number: NCT04728906
• Lead Sponsor: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-26
• Study First Submitted QC: 2021-01-27
• Study First Posted: 2021-01-28
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-02
• Study Start: 2022-04-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Heart patch + cardiomyocytes - hAESC	Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells	Patients who undergo bypass (CABG) surgery are given heart patch in areas where grafting (bypass) is not feasible

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Rumah Sakit Universitas Indonesia; 🇮🇩 Depok, Jawa Barat, Indonesia

RSUPN dr. Cipto Mangunkusumo; 🇮🇩 Jakarta, DKI Jakarta, Indonesia

Pusat Jantung Nasional Harapan Kita; 🇮🇩 Jakarta, Indonesia