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 @ 2:32 AM
Ignite Modification Date:
2025-12-25 @ 2:32 AM
NCT ID:
NCT05984134
Eligibility Criteria:
Inclusion Criteria:
1. The subjects or their guardians voluntarily participate in the experiment and sign the informed consent;
2. Age ≥18 years old and ≤75 years old, gender is not limited;
3. STEMI patients with proximal or/and middle occlusion of a single left anterior descending artery (TIMI grade 0-1) and PCI;
4. No coronary collateral (Rentrop grade 0);
5. meet one of the following conditions:
* The total myocardial ischemia time before PCI was \< 6 hours, and the TIMI grade after PCI was \< 3
* 6 hours ≤ Total myocardial ischemia time before PCI ≤24 hours Note: Total myocardial ischemia time =PCI wire passage time - start time of chest pain
6. All subjects (male and female) must agree to use appropriate contraceptive methods (hormonal or barrier methods, abstinence) during study participation and up to 6 months of the last dosing, and women of childbearing age must test negative for pregnancy before dosing.
Exclusion Criteria:
1. Patients with a history of myocardial infarction who have received acute coronary thrombolysis, interventional therapy, or bypass surgery; A clear diagnosis of acute heart failure (Killip grade ≥III);
2. Severe arrhythmias that cannot be corrected;
3. Aortic dissection;
4. Severe liver and kidney dysfunction or severe consumption;
5. History of major surgery or hemorrhagic stroke within six months;
6. Previous history of malignant tumors;
7. Hypertensive patients with systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg after active antihypertensive treatment;
8. Clinically significant allergic reaction history, especially mannitol, drugs, protein preparations, biological products;
9. Patients who participated in other clinical studies within 3 months prior to screening;
10. Can not perform CMR examination;
11. Other conditions deemed unsuitable for inclusion by the investigators (for example, those whose coronary arteries other than the left anterior descending branch were judged by the investigators to require elective revascularization therapy at the same time or within 1 month).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05984134
Study Brief:
Protocol Section:
NCT05984134