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Clinical Trials/NCT04734587
NCT04734587
Completed
Not Applicable

Assessment of Silent Brain Injury in Chronic Total Occlusion Patients With Percutaneous Coronary Intervention

Ondokuz Mayıs University1 site in 1 country120 target enrollmentJanuary 18, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Silent Stroke
Sponsor
Ondokuz Mayıs University
Enrollment
120
Locations
1
Primary Endpoint
Baseline Neuron-specific Enolase (NSE) measurement
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

This study examines the formation mechanism and patient-related factors of silent cerebral infarcts, whose importance has become increasingly recognized in patients undergoing percutaneous coronary intervention.

Detailed Description

This study was produced from the assistant's thesis and was previously accepted as a poster at EuroPCR 2020. We recently completed the full-length article. This thesis study was supported by Ondokuzmayis University.

Registry
clinicaltrials.gov
Start Date
January 18, 2019
End Date
March 25, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ondokuz Mayıs University
Responsible Party
Principal Investigator
Principal Investigator

Muhammet Uyanik

Principal Investigator

Ondokuz Mayıs University

Eligibility Criteria

Inclusion Criteria

  • CTO and Non-CTO patients undergoing percutaneous coronary intervention

Exclusion Criteria

  • baseline NSE elevation
  • acute coronary syndromes or cardiac surgery within 4 weeks
  • patients with a cerebrovascular accident
  • intracranial hemorrhage
  • and head trauma
  • central nervous system tumor
  • degenerative central nervous system disorders and neuroendocrine tumors

Outcomes

Primary Outcomes

Baseline Neuron-specific Enolase (NSE) measurement

Time Frame: NSE blood levels were measured 1-2 hours before the procedure.

Baseline NSE measurement to exclude non-PCI dependent brain injury. Elevation of \>20 ng/ml was considered as silent brain injury. Patients with basal nse elevation were considered as SBI and excluded from the study.

Silent Brain Injury diagnosis

Time Frame: 12-18 hours after percutaneous coronary intervention

NSE blood levels were measured 12-18 hours after the procedure. Elevation of \>20 ng/ml was considered as SBI.

Study Sites (1)

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