Evaluation of the safety and feasibility of FSTL-1 cardiac patch

Phase 1

• Conditions: Condition 1: ST-segment elevation MI. Condition 2: Ischaemic Heart failure.; ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction; Heart failure

• Registration Number: IRCT20210827052304N1
• Lead Sponsor: ational institute for medical search development (NIMAD)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Age between 18 and 80 years old
The first-time episode of myocardial infarction (MI)
ST-elevation on the patient's electrocardiogram (ECG)
Recommendation of isolated coronary artery bypass (CABG) by treating cardiologists or cardiac surgeons after conducting coronary angiography
Less than 3 months delay between MI and upcoming operation
Ejection fraction = 20% and = 40%
Ischemia (rather than other cardiac problems) causing heart failure
No planning for pregnancy during the study period for female participants

Exclusion Criteria

Previous history of constrictive pericarditis
Past history of surgery on pericardium
Pregnancy
Being on immunosuppressive therapy
Corticosteroid medications, or chemotherapy (or any plan for being on such treatments within the next 6 months after recruitment)
Current or past history of cancer
Current or previous history of autoimmune disorders
Severe renal disorder (glomerular filtration rate < 60 ml/min/1.73 m2
Being a candidate for any types of cardiac surgery concomitant with coronary artery bypass surgery
Having malignant ventricular arrhythmia or atrial flutter
Severe mitral valve stenosis or insufficiency
Severe aortic valve stenosis or insufficiency
Patients with poor echo views
Severe hepatic failure or cirrhosis
Estimated life expectancy of less than one year
Previous history for undergoing cardiac surgery
Any contraindication for conducting cardiac magnetic resonance image
Any tendency for perioperative bleeding (international normalized ratio > 1.5)
Having pulmonary disease with forced expiratory volume < 50% or diffusing capacity of the lungs for carbon monoxide < 50%
Having dementia, Alzheimer, Parkinsonism, and/or previous stroke with physical secuela.

Study & Design

• Study Type: interventional
• Study Design: Not specified