Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-25 @ 4:42 AM
NCT ID:
NCT05485818
Eligibility Criteria:
Inclusion Criteria:
1. The subject or its legal representative will voluntarily participate in the study and sign the informed consent;
2. Age 18 and 75, regardless of gender;
3. STEMI patients with left anterior descending branch single-artery middle occlusion (TIMI grading 0\~1, see Appendix 1 for TIMI grading) and receiving PCI;
4. No obvious collateral of coronary artery (Rentrop grade 0\~1,Rentrop grade see Appendix 2);
5. Chest pain occurred for 6 hours and 12 hours before PCI;
6. TIMI grade 3 after PCI;
7. All subjects (male and female) must agree to use appropriate contraceptive methods (hormonal or barrier contraceptive methods, abstinence) during the study period and up to 6 months after the last administration, and women of childbearing age must test negative for pregnancy before administration.
Exclusion Criteria:
1. Patients who have a history of myocardial infarction or have received coronary artery acute thrombolytic interventional therapy with bypass surgery;
2. patients who received thrombolytic therapy after onset;
3. patients who were clearly diagnosed as acute heart failure (Killip grade II,Killip classification in annex 3);
4. Severe arrhythmia that cannot be corrected;
5. Aortic dissection or suspected presence;
6. Severe liver and kidney dysfunction or severe depletion, etc;
7. major surgical history or hemorrhagic stroke in half a year;
8. Has or has a history of malignancy;
9. Systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg in patients with hypertension after active antihypertensive treatment;
10. Clinically, he had a significant history of allergy, especially to mannitol, drugs, protein preparations and biological products;
11. Screening of patients who participated in other clinical studies within the first 3 months;
12. Failure to perform CMR test: such as claustrophobia, renal failure (eGFR \< 30ml/min);
13. Other conditions not considered suitable for inclusion by the researcher.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05485818
Study Brief:
Protocol Section:
NCT05485818