Clinical Trials Directory

Trials / Completed

CompletedNCT06552442

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Amosov National Institute of Cardiovascular Surgery · Academic / Other
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGMethylprednisoloneHigh-dose intracoronary glucocorticoid methylprednisolone to abrogate no-reflow: a unique study for restoration of infarct-related artery patency and reduction of ischemia-reperfusion injury

Timeline

Start date
2020-09-05
Primary completion
2024-01-01
Completion
2024-06-01
First posted
2024-08-14
Last updated
2024-08-14

Locations

1 site across 1 country: Ukraine

Source: ClinicalTrials.gov record NCT06552442. Inclusion in this directory is not an endorsement.