Ischemia-reperfusion Injury, No-reflow
Conditions
Keywords
acute coronary syndrome, STEMI, No-reflow, Intracoronary, Glucocorticoids
Brief summary
The goal of this clinical trial is to improve reperfusion therapy in STEMI patients with no-reflow phenomenon. Based on literature review and pathological studies, the investigators believe that myocardial ischemia-reperfusion injury is primarily due to myocardial edema, which is angiographically manifested by the no-reflow. To restore blood flow, high-dose intracoronary methylprednisolone was applied. The main idea is to stabilize cell membranes and stop the progression of edema. It is local, not systemic, single administration that avoids serious side effects. The primary hypothesis is that hormone administration will improve blood flow to TIMI 2/3 in TIMI 0/1after stenting infarct-related artery.
Detailed description
The study involves comparing the main group receiving intracoronary methylprednisolone with a group of patients without intracoronary pharmacotherapy. Preliminary results: the use of methylprednisolone allows for the restoration of coronary blood flow but does not affect mortality.
Interventions
DRUGMethylprednisolone
High-dose intracoronary glucocorticoid methylprednisolone to abrogate no-reflow: a unique study for restoration of infarct-related artery patency and reduction of ischemia-reperfusion injury
Sponsors
Amosov National Institute of Cardiovascular Surgery
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
The main study group receives intracoronary methylprednisolone for the no-reflow phenomenon. The control group does not receive any pharmacological intervention. Considering that this complication is very rare, the control group was selected retrospectively.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* TIMI 0/1 flow after successful artery obstruction stenting * Men and women aged 40 years and older
Exclusion criteria
* Coronary artery dissection * Abrupt intraoperative coronary artery closure * Intraoperative thrombosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Restoration of coronary blood flow | 3 minutes | Degree of restoration of coronary blood flow on the Thrombolysis in myocardial infarction (ТIMI) grade 0-3 (3 is the best result, 0/1 - bad or no-reflow) from TIMI 0 or TIMI 1 to TIMI 2 or TIMI 3 |
Countries
Ukraine
Outcome results
None listed