Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The OPERA-MI trial evaluates the effect of i.v. ferric carboxymaltose compared to the effect of oral iron, on left ventricular systolic function.
For this study an open-label prospective randomized approach is used. During the study 360 patients with or without ID, who hospitalized for myocardial infarction were signed up. Patients were randomised (1:1) to either intravenous. FCM or oral ferrous sulphate and received the treatment during hospitalisation. Patients are closely followed for 1 year. The primary outcome is a decrease in the Wall Motion Score Index value in FCM group compered to ferrous sulphate group. The main secondary outcome includes the composite of cardio-vascular mortality, non-fatal stroke, non-fatal MI, recurrent heart failure hospitalizations.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FCM group | Active Comparator | The ferric carboxymaltose doses were determined using the patient's screening visit body weight measurement and haemoglobin value. Patients receives all doses during hospitalization accordance with the drug local labels. |
|
| Ferrous sulphate group | Active Comparator | 100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month. |
|
| Group with normal iron status | No Intervention | Patiants with normal iron status |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ferric carboxymaltose | Drug | ferric carboxymaltose is i.v. iron, 99 patiants will be randomised to this group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in the Wall Motion Score Index | Using a standard transthoracic echocardiography sequence, each myocardial segment is assigned a score from 1 to 3. we used the 16 segment model of myocardial segmentation Each segment is then scored, using the following criteria: normokinesia (1 point) normal wall thickening and endocardial excursion hypokinesia (2 points) reduced wall thickening, reduced endocardial excursion akinesia (3 points) The wall motion score index is then calculated by dividing the sum of the aforementioned segmental values by the number of myocardial segments (16). A WMSI of 1.0 (16/16) is considered normokinetic, and correlates with a CMRI calculated ejection fraction of 64%, whereas a WMSI of 3.0 correlates with an ejection fraction of 12% and is considered akinetic. There are no spetial units of measure for it. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Outcome | composite of cardio-vascular (CV) mortality, non-fatal stroke, non-fatal MI, recurrent HF hospitalizations. | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kazan State Medical Universety | Kazan' | Tatarstan Republic | 420012 | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | FCM Group | The ferric carboxymaltose doses were determined using the patient's screening visit body weight measurement and haemoglobin value. Patients receives all doses during hospitalization accordance with the drug local labels. ferric carboxymaltose: ferric carboxymaltose is i.v. iron, 121 patiants will be randomised to this group |
| FG001 | Ferrous Sulphate Group | 100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month. ferrous sulphate: ferrous sulphate is oral iron, 121patiants will be randomised to this group |
| FG002 | Group With Normal Iron Status | Patiants with normal iron status |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | FCM Group | The ferric carboxymaltose doses were determined using the patient's screening visit body weight measurement and haemoglobin value. Patients receives all doses during hospitalization accordance with the drug local labels. ferric carboxymaltose: ferric carboxymaltose is i.v. iron, 121 patiants will be randomised to this group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Decrease in the Wall Motion Score Index | Using a standard transthoracic echocardiography sequence, each myocardial segment is assigned a score from 1 to 3. we used the 16 segment model of myocardial segmentation Each segment is then scored, using the following criteria: normokinesia (1 point) normal wall thickening and endocardial excursion hypokinesia (2 points) reduced wall thickening, reduced endocardial excursion akinesia (3 points) The wall motion score index is then calculated by dividing the sum of the aforementioned segmental values by the number of myocardial segments (16). A WMSI of 1.0 (16/16) is considered normokinetic, and correlates with a CMRI calculated ejection fraction of 64%, whereas a WMSI of 3.0 correlates with an ejection fraction of 12% and is considered akinetic. There are no spetial units of measure for it. | Posted | Count of Participants | Participants | 1 year |
|
1 year
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FCM Group | The ferric carboxymaltose doses were determined using the patient's screening visit body weight measurement and haemoglobin value. Patients receives all doses during hospitalization accordance with the drug local labels. ferric carboxymaltose: ferric carboxymaltose is i.v. iron, 121 patiants will be randomised to this group |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Niiaz Khasanov | Kazan State medical Universety | +79050204407 | dilyara_khastieva@mail.ru |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 1, 2022 | Oct 13, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| C020748 | ferrous sulfate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ferrous sulphate | Drug | ferrous sulphate is oral iron, 100 patiants will be randomised to this group |
|
| BG001 |
| Ferrous Sulphate Group |
100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month. ferrous sulphate: ferrous sulphate is oral iron, 121patiants will be randomised to this group |
| BG002 | Group With Normal Iron Status | Patiants with normal iron status |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Ferrous sulphate group | 100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month. ferrous sulphate: ferrous sulphate is oral iron, 121patiants will be randomised to this group |
| OG002 | Group with normal iron status | Patiants with normal iron status |
|
|
| Secondary | Composite Outcome | composite of cardio-vascular (CV) mortality, non-fatal stroke, non-fatal MI, recurrent HF hospitalizations. | Not Posted | 1 year | Participants |
| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | Ferrous Sulphate Group | 100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month. ferrous sulphate: ferrous sulphate is oral iron, 121patiants will be randomised to this group | 0 | 100 | 0 | 100 | 0 | 100 |
| EG002 | Group With Normal Iron Status | Patiants with normal iron status | 0 | 99 | 0 | 99 | 0 | 99 |
Not provided
Not provided
Not provided
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |