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:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT05466968
Eligibility Criteria:
Inclusion Criteria:
1. Between the ages of 18-75;
2. Meet the diagnosis of AMI global definition version 4，admit from emergency department;
3. Prepare for emergency coronary angiography and PCI reperfusion therapy;
4. Volunteer to participate in this study and have signed an informed consent form.
Exclusion Criteria:
1. AMI with cardiogenic shock (Killip grade ≥ grade III) and no response to vasopressin;
2. AMI complicated with severe arrhythmia (persistent ventricular tachycardia, ventricular fibrillation);
3. AMI complicated with mechanical complications (ventricular septal perforation, papillary muscle rupture, intracardiac thrombus, ventricular free wall rupture);
4. Severe systemic diseases (immune system diseases, sepsis and other serious infections, blood system diseases, massive hemorrhage caused by anticoagulation and antithrombotic therapy, and severe organ failure (such as ALT ≥ 3 ULN, cr\> 134 μ Mol/l (2mg/dl) or egfr\<45ml/min/1.73m2);
5. History of cerebral hemorrhage and cerebral aneurysm within 3 months;
6. Mental patients;
7. Malignant tumor or other pathophysiological condition with expected survival less than 1 year;
8. Those who are allergic to the drug components of this study;
9. Pregnant or lactating women;
10. Patients who have participated in clinical trials of other drugs within 3 months before enrollment or took other Chinese patent medicines with similar effects within the first three months of enrollment;
11. Other diseases with clinical significance that may cause serious danger to patients.
12. In TCM syndrome types, Qi deficiency, Yang deficiency and other deficiency syndrome types, and cold congealing heart pulse syndrome types in positive syndrome types.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT05466968
Study Brief:
Protocol Section:
NCT05466968