NCT05309499Completed
An Open Study on the Efficacy of Iron Therapy Using iv Iron Relative to Oral Iron for Increasing LV Systolic Function
An Open, Prospective, Randomized Study on the Efficacy of Iron Therapy Using Intravenous (IV) Iron Supplements Relative to Oral Iron Intake for Increasing Left Ventricular Systolic Function in Patients With Myocardial Infarction
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
The OPERA-MI trial evaluates the effect of i.v. ferric carboxymaltose compared to the effect of oral iron, on left ventricular systolic function.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 298 (actual)
- First submitted
- 24 Mar 2022
- Start date
- 5 Dec 2021
- Primary completion date
- 15 Sept 2025
- Lead sponsor
- Kazan State Medical University
- Diseases
- Coronary artery disease
- NCT number
- NCT05309499
What you commit to
- Study type: Interventional
- Participants enrolled: 298
- From 5 Dec 2021 to the primary completion date, 15 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
Other illness
- Known hypersensitivity reaction to any component of ferric carboxymaltose.
- History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, i.v. iron therapy, or blood transfusion.
- Heart failure Killip class II-IV on screening visit.
- Current or planned mechanical circulatory support or heart transplantation.
- Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
- Active gastrointestinal bleeding.
Lab values
- Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase \>3 times the upper limit of normal range).
Other
- Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
- Inability to return for follow up visits within the necessary period of time.
Who the study is looking for
- Adult (≥18 years of age) able to provide informed consent. Hospitalized myocardial infarction patients (that diagnosed according to Fourth Universal Definition of myocardial infarction and myocardial injury, ESC 2018) with hypokinesia or akinesia in at least two connected left ventricular segments according to echocardiography results obtained within the first 24 hours after myocardial infarction occurs.
- Hemoglobin \>9.0 g/dL and \<15,0 g/dl and serum iron \<12 µmol/l on screening visit.
- Serum ferritin \<100 μg/L, or 100-299 μg/L when transferrin saturation \<20%.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kazan State Medical Universety Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.