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

NCT06552442 | Completed Phase 2

• 1 other identifier: Ethics Protocol Number 1/2020
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemia-reperfusion Injury; No-reflow

Keywords

acute coronary syndrome; STEMI; No-reflow; Intracoronary; Glucocorticoids

Outcome Measures

Primary Outcomes (1)

• Restoration of coronary blood flow

  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

  3 minutes

Study Arms (2)

Main group

EXPERIMENTAL

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.

Drug: Methylprednisolone

Control group

NO INTERVENTION

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.

Interventions

Methylprednisolone DRUG

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

Main group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• TIMI 0/1 flow after successful artery obstruction stenting
• Men and women aged 40 years and older

You may not qualify if:

• Coronary artery dissection
• Abrupt intraoperative coronary artery closure
• Intraoperative thrombosis

Sponsors & Collaborators

• Amosov National Institute of Cardiovascular Surgery: lead

Study Sites (1)

Amosov National Institute of cardiovascular surgery

Kyiv, Amosov Street, 6, 03038, Ukraine

Location

MeSH Terms

Conditions

Reperfusion Injury; Acute Coronary Syndrome; ST Elevation Myocardial Infarction

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Heart Diseases; Myocardial Infarction; Infarction; Ischemia; Necrosis

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: August 14, 2024
• Study Start: September 5, 2020
• Primary Completion: January 1, 2024
• Study Completion: June 1, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

UA (1)