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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07380659
Eligibility Criteria:
Inclusion Criteria（patients）:
* Age ≥ 18 years and \< 80 years.
* Acute ST-segment elevation myocardial infarction (STEMI) complicated by cardiogenic shock, meeting all the following conditions:
1. Post-emergent revascularization (PCI or CABG)
2. Systolic blood pressure \< 90 mmHg for \>30 minutes, or requiring catecholamine support to maintain systolic blood pressure \>90 mmHg
3. Signs of impaired organ perfusion, meeting at least one of the following criteria:
1. Altered mental status
2. Cold, clammy skin and extremities
3. Oliguria, with urine output \<30 mL/h
4. Arterial lactate level \>2 mmol/L
* The patient or their legally authorized representative is capable of providing verbal confirmation of understanding the trial risks, benefits, and treatment alternatives associated with receiving immunosuppressive CAR-DC therapy, and provides written informed consent prior to participation in this clinical trial.
Exclusion Criteria（patients）:
1. Acute mechanical complications of infarction (e.g., ventricular septal rupture, acute mitral regurgitation).
2. Cardiac arrest.
3. Hypoxic-ischemic brain injury (cerebral injury with fixed and dilated pupils not attributable to medication).
4. Shock due to other causes (e.g., sepsis, hypovolemia).
5. Resuscitation duration \>30 minutes.
6. Absence of spontaneous cardiac activity.
7. Persistent electrical instability.
8. Active bleeding or contraindications to heparin use.
9. Active autoimmune disease requiring immunosuppressive therapy.
10. History of malignancy.
11. Infection, including:
* Active hepatitis B (HBV DNA \>1000 copies/mL by PCR), hepatitis C, syphilis, or HIV infection at screening.
* Uncontrolled systemic fungal, bacterial, viral, or other pathogen infections.
12. Pregnant women.
13. Contraindications to the investigational drug or study procedures.
Inclusion Criteria（donors）:
* Age ≥ 18 years and ≤ 75 years.
* Has provided written informed consent.
* Hematocrit \>30%, lymphocyte count \>0.5 × 10\^9/L, platelet count \>60 × 10\^9/L.
* Pathogen screening results must be negative for HIV (antigen, core antibody, and RNA), HBV (surface antigen and core antibody), HCV, syphilis, CMV, and EBV.
Exclusion Criteria（donors）:
* Active infection requiring treatment.
* History of malignancy.
* Active autoimmune disease requiring immunosuppressive therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07380659
Study Brief:
Protocol Section:
NCT07380659