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

August 12, 2024 updated by: Amosov National Institute of Cardiovascular Surgery

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ukraine
    • Amosov Street, 6
      • Kyiv, Amosov Street, 6, Ukraine, 03038
        • Amosov National Institute of cardiovascular surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Main group

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
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
No Intervention: Control group

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration of coronary blood flow
Time Frame: 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
3 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amosov National Institute of Cardiovascular Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2020

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

July 10, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 12, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ethics Protocol Number 1/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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