Intracoronary Administration of Glucocorticoids as a Treatment Method for No-Glucocorticoid Treatment for No-Reflow in STEMI (GCT-NR-STEMI)

Amosov National Institute of Cardiovascular Surgery

Status and phase: Completed; Phase 2

Conditions: No-reflow; Ischemia-reperfusion Injury

Treatments: Drug: Methylprednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT06552442

Ethics Protocol Number 1/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Main group

Experimental group

Description:

Main group - 10 patients. STEMI patients with the occurrence of the no-reflow phenomenon after stenting of the infarct-related artery. Treatment of the phenomenon: intracoronary administration of methylprednisolone.

Treatment:

Drug: Methylprednisolone

Control group

No Intervention group

Description:

Control group - 10 patients. STEMI patients with the occurrence of the no-reflow phenomenon after stenting of the infarct-related artery. Treatment of the phenomenon: no pharmacological intervention.