Iron-deficiency, Myocardial Infarction
Conditions
Keywords
Myocardial Infarction, Iron-deficiency, WMSI, ferric carboxymaltose, left ventricular systolic function
Brief summary
The OPERA-MI trial evaluates the effect of i.v. ferric carboxymaltose compared to the effect of oral iron, on left ventricular systolic function.
Detailed description
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.
Interventions
DRUGferric carboxymaltose
ferric carboxymaltose is i.v. iron, 99 patiants will be randomised to this group
DRUGferrous sulphate
ferrous sulphate is oral iron, 100 patiants will be randomised to this group
Sponsors
Kazan State Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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%.
Exclusion criteria
* 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. * Hemodialysis or peritoneal dialysis (current or planned within the next 6 months). * Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase \>3 times the upper limit of normal range). * 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. * 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. * Inability to return for follow up visits within the necessary period of time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decrease in the Wall Motion Score Index | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite Outcome | 1 year | composite of cardio-vascular (CV) mortality, non-fatal stroke, non-fatal MI, recurrent HF hospitalizations. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 99 |
| 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 | 100 |
| Group With Normal Iron Status Patiants with normal iron status | 99 |
| Total | 298 |
Baseline characteristics
| Characteristic | FCM Group | Ferrous Sulphate Group | Group With Normal Iron Status | Total |
|---|---|---|---|---|
| Age, Continuous | 66.3 years STANDARD_DEVIATION 10.2 | 64.3 years STANDARD_DEVIATION 8.8 | 66.1 years STANDARD_DEVIATION 10 | 65.7 years STANDARD_DEVIATION 8.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 99 Participants | 100 Participants | 99 Participants | 298 Participants |
| Sex: Female, Male Female | 49 Participants | 40 Participants | 24 Participants | 113 Participants |
| Sex: Female, Male Male | 50 Participants | 60 Participants | 75 Participants | 185 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 99 | 0 / 100 | 0 / 99 |
| other Total, other adverse events | 0 / 99 | 0 / 100 | 0 / 99 |
| serious Total, serious adverse events | 0 / 99 | 0 / 100 | 0 / 99 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FCM group | Decrease in the Wall Motion Score Index | 53 Participants |
| Ferrous sulphate group | Decrease in the Wall Motion Score Index | 58 Participants |
| Group with normal iron status | Decrease in the Wall Motion Score Index | 46 Participants |
Secondary
Composite Outcome
composite of cardio-vascular (CV) mortality, non-fatal stroke, non-fatal MI, recurrent HF hospitalizations.
Time frame: 1 year