Intracoronary Administration of Glucocorticoids as a Treatment Method for No-Glucocorticoid Treatment for No-Reflow in STEMI

Phase 2

Completed

• Conditions: Ischemia-reperfusion Injury; No-reflow
• Interventions: Drug: Methylprednisolone

• Registration Number: NCT06552442
• Lead Sponsor: Amosov National Institute of Cardiovascular Surgery

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.

Study Timeline

• Study Start: 2020-09-05
• Primary Completion: 2024-01-01
• Study Completion: 2024-06-01
• Study First Submitted: 2024-07-10
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Main group	Methylprednisolone	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Amosov National Institute of cardiovascular surgery; 🇺🇦 Kyiv, Amosov Street, 6, Ukraine