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:
NCT07476859
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 65 years.
2. Hospitalization for confirmed acute coronary syndrome (ACS) within 15 days prior to enrollment.
3. Iron deficiency diagnosed at admission or within 15 days after the index ACS event, defined as:
* Serum ferritin \< 100 ng/mL, OR
* Transferrin saturation (TSAT) \< 20%.
4. Ability to provide written informed consent prior to participation.
Exclusion Criteria:
1. Active malignancy.
2. End-stage or terminal illness as determined by the IDC-Pal score.
3. Known heart failure with left ventricular ejection fraction (LVEF) \< 40% prior to enrollment, or development of LVEF \< 40% during hospitalization or within 15 days after ACS.
4. Chronic dialysis or advanced renal or hepatic failure.
5. Severe anemia (hemoglobin \< 10 g/dL) at the time of ACS or within 15 days after the event.
6. Prior treatment with intravenous or oral iron within 12 months before the index ACS.
7. Known hypersensitivity to ferric carboxymaltose, other parenteral iron products, or any component of the formulation.
8. Evidence of iron overload or disorders of iron metabolism.
9. Ongoing bacteremia or active systemic infection.
10. Participation in another interventional clinical trial involving an investigational medicinal product.
11. Any condition that, in the investigator's opinion, would compromise safety, protocol compliance, or study integrity.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT07476859
Study Brief:
Protocol Section:
NCT07476859