ischemic heart disease
Conditions
Interventions
Sham Control Group:Sham Control
Active Treatment Group:Circular RNA-HM2002 Injection
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 and <=80 years at the time of signing the Informed Consent Form (ICF), regardless of gender. 2. Patients clinically diagnosed with Ischemic Heart Disease (IHD) according to the latest clinical practice guidelines and judged to have an indication for Coronary Artery Bypass Grafting (CABG) surgery. 3. Left Ventricular Ejection Fraction (LVEF) < 50% confirmed by echocardiogram (ECHO), New York Heart Association (NYHA) Functional Classification Class II-IV, and scheduled to undergo elective CABG surgery. 4. Subjects of childbearing potential must agree to use effective medical contraceptive measures (for both male and female subjects, until 90 days after administration). 5. Capable of understanding the study content, procedures, and potential adverse reactions, and willing to comply with the protocol requirements for safety and efficacy assessments and follow-up, with good compliance.
Exclusion criteria
Exclusion criteria: 1. Severe Left Ventricular (LV) dysfunction, with LVEF 70 mmHg. 11. Participation in any other clinical study within 3 months prior to screening. 12. Body Mass Index (BMI) > 40 kg/m^2 or = 5 years prior to the study treatment; or cured basal cell or squamous cell carcinoma of the skin, papillary thyroid carcinoma, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast. 15. For diabetic patients, HbA1c > 8.5% at screening or presence of active diabetic retinopathy. 16. Subjects with Human Immunodeficiency Virus (HIV), Syphilis, Hepatitis C Virus (HCV), or Hepatitis B Virus (HBV) infection at screening, who meet the following conditions: a. HBsAg positive AND HBV DNA >= 2500 copies/ml (or 500 IU/ml); b. Anti-HCV antibody positive AND HCV RNA positive; c. HIV antibody positive; d. Syphilis specific antibody positive AND non-specific antibody positive. 17. Any of the following abnormal clinical laboratory findings at screening: • White Blood Cell (WBC) count = 3 × Upper Limit of Normal (ULN); • Total Bilirubin >= 1.5 × ULN; • Estimated Glomerular Filtration Rate (eGFR) <= 35 mL/min/1.73 m^2. 18. Intolerance or contraindication to the study treatment regimen, including any of the following: a. History of severe allergies or immune-mediated hypersensitivity reaction;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Safety and Tolerability Events (DLT, AE, SAE, MACE);Maximum Tolerated Dose (MTD); | — |
Secondary
| Measure | Time frame |
|---|---|
| Characteristics of Change in Expressed Protein VEGF-A in Peripheral Blood;Change in Angina Score Measured by Seattle Angina Questionnaire (SAQ);Change in LVEF Assessed by Cardiac Magnetic Resonance Imaging (CMRI);Change in Heart Failure and Myocardial Injury Biomarkers;Change in Quality of Life (QoL) Assessed by Minnesota Living with Heart Failure Questionnaire;Change in New York Heart Association (NYHA) Functional Classification;Pharmacokinetic (PK) Characteristics of Circular RNA-HM2002 in Peripheral Blood;Change in Left Ventricular Functional Parameters Measured by ECHO;Immunogenicity Monitoring;Change in Perfusion and Metabolism in the Ischemic Myocardial Injection Segment; | — |
Countries
China
Contacts
Public ContactQiang Zhao
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed