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 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT04663932
Eligibility Criteria:
Inclusion Criteria:
* Inpatients who meet all of the following criteria can be included in the study:
1. Age: 18-75 years old;
2. A confirmed diagnosis of STEMI with symptom onset within 12 h;
STEMI criteria:
1. Patient has a history of chest pain/discomfort;
2. ST elevation ≥ 0.1 mV in at least two contiguous leads of an ECG on admission (\> 30 minutes; ≥ 0.2 mV required for V2 and V3 ) or the development of new left bundle branch block (LBBB);
3. an increase in cardiac biomarkers (troponin, CK-MB) above the 99th percentile of the laboratory upper reference limit; 3. Time from FMC to wire crossing estimated to be \> 120 min; 4. Has a target vessel with TIMI grade 3 flow shown as by CAG and ≥ 50% angiographic stenosis after thrombus aspiration; 5. Has culprit lesions identified as primary lesions; 6. Signed the written informed consent form.
Exclusion Criteria:
* Patients are not eligible for enrollment if they meet any of the following criteria:
1. A contraindication to thrombolysis;
2. An estimated survival time ≤ 12 months;
3. Known heart failure of Killip class III or above, or mechanical complications such as heart rupture;
4. Known to be participating in any other clinical trial;
5. Pregnant or lactating women, or women experiencing their menstrual period;
6. Weight \< 40 Kg or \> 125 Kg;
7. Known allergies to drugs that are required during the study such as contrast agents, antiplatelet drugs, and anticoagulants;
8. A target vessel with TIMI grade 0-2 flow as revealed by the initial CAG;
9. Having lesions located in the LMCA or root of the LAD, or with severe multiple vessel disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04663932
Study Brief:
Protocol Section:
NCT04663932