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Effect of intravenous iron on quality of life in older adults with acute coronary syndrome: a phase IV clinical study
EU CTIS ID: 2025-522421-36-00
What this study is testing
To determine whether patients aged 65 years or older, diagnosed with iron deficiency after an acute coronary syndrome (ACS), who receive intravenous iron treatment have a better quality of life at 6 and 12 months of follow-up compared to patients who do not receive treatment.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients aged 65 years or older.
- Patients with a confirmed diagnosis of acute coronary syndrome (ACS) within a maximum of 15 days prior to inclusion.
- Patients with a confirmed diagnosis of iron deficiency at the time of hospital admission or within 15 days after the cardiac event, untreated, and defined by: - Serum ferritin <100 ng/mL, or - Transferrin saturation (TSAT) <20%, according to the European Society of Cardiology guidelines and the SEC_SEMI consensus.
- Ability to understand the study details and to provide written informed consent prior to any trial-related procedures.
You likely can't join if
- Patients with active cancer.
- Patients with ongoing bacteremia.
- Patients currently participating in other clinical trials involving investigational medicinal products.
- Patients who, in the opinion of the investigator, should not participate in the study due to difficulties in complying with procedures, restrictions, or requirements.
- Terminally ill patients as determined by the IDC-Pal score (Instrument for Diagnosing Complexity in Palliative Care).
- Patients with a prior diagnosis of heart failure (HF) with a left ventricular ejection fraction (LVEF) <40%, or who develop this condition during hospitalization or within 15 days following the acute coronary syndrome (ACS) event will be excluded.
See the full eligibility criteria
- Patients aged 65 years or older.
- Patients with a confirmed diagnosis of acute coronary syndrome (ACS) within a maximum of 15 days prior to inclusion.
- Patients with a confirmed diagnosis of iron deficiency at the time of hospital admission or within 15 days after the cardiac event, untreated, and defined by: - Serum ferritin <100 ng/mL, or - Transferrin saturation (TSAT) <20%, according to the European Society of Cardiology guidelines and the SEC_SEMI consensus.
- Ability to understand the study details and to provide written informed consent prior to any trial-related procedures.
- Patients with active cancer.
- Patients with ongoing bacteremia.
- Patients currently participating in other clinical trials involving investigational medicinal products.
- Patients who, in the opinion of the investigator, should not participate in the study due to difficulties in complying with procedures, restrictions, or requirements.
- Terminally ill patients as determined by the IDC-Pal score (Instrument for Diagnosing Complexity in Palliative Care).
- Patients with a prior diagnosis of heart failure (HF) with a left ventricular ejection fraction (LVEF) <40%, or who develop this condition during hospitalization or within 15 days following the acute coronary syndrome (ACS) event will be excluded.
- Patients undergoing dialysis, or with advanced hepatic or renal failure.
- Patients with severe anemia (hemoglobin <10 g/dL) at the time of the event or within the subsequent 15 days.
- Patients with previously diagnosed iron deficiency, identified and treated with intravenous or oral iron within the year prior to the event.
- Patients with known hypersensitivity to intravenous iron or to any of the excipients in the product.
- Patients with known severe hypersensitivity to other parenteral iron products.
- Evidence of iron overload or disorders in iron utilization.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.