A Research Study to Evaluate the Safety and Preliminary Efficacy of SGC001 in Patients With Myocardial Infarction

Korábbi kezelés

• Individuals with the following medical histories:
  • Myocardial infarction and coronary revascularization
  • Cardiopulmonary resuscitation
  • Stroke within 6 months before the first dose
  • Aortic dissection
• Individuals who received thrombolytic therapy;
• Individuals who have participated in other drug clinical studies and received other clinical trial drugs within 1 months prior to receiving the investigational drug;
• Women of childbearing potential (WOCBP) or men who plan to father a child or whose partners plan to become pregnant from screening until 3 months after receiving the investigational product; pregnant or lactating women;

Más betegség

• Individuals who have recent febrile infection, requiring systemic treatment;
• Individuals with cardiogenic shock or hemodynamic instability (such as severe arrhythmia), including systolic blood pressure <90 mmHg;
• Individuals with clear diagnosis of acute heart failure (Killip grade ≥ III, Killip grade is detailed in appendix);
• Individuals who cannot undergo cardiovascular magnetic resonance (CMR) testing or are known to be allergic to any radio-contrast agent;
• Individuals with the following medical histories:
  • severe liver and renal insufficiency;
  • Patients with malignant tumors or previous history of malignant tumors;
  • Severe autoimmune disease requiring therapeutic intervention;

Egyéb

• Any other circumstance that, in the judgement of the investigator, may affect the ability of the subject to provide informed consent or to follow the trial protocol, or where the subject's participation in the trial may affect the outcome of the trial or his or her safety.

• Male or female subjects aged 18~75 years (both inclusive)
• Anterior STEMI, defined as: (a) Persistent chest pain or discomfort > 30 minutes; AND (b) Persistent ST-segment elevation ≥0.1 mV in ≥2 contiguous precordial leads (V1-V6) on the admission ECG, with ≥0.2 mV required in leads V2 and V3; OR, if （a）clinical symptoms are atypical, (c) a positive point-of-care cardiac troponin test is required.
• Ability to receive study drug administration within 6 hours of symptom onset, as assessed by the investigator;
• Subjects who fully understand the purpose, nature, method, and potential adverse reactions of the trial, and who voluntarily sign the informed consent form and agree to participate in the study;