Evaluation of Brain Damage Due to Coronary Angioplasty in Percutaneous Intervention Patients

Completed

• Conditions: Silent Stroke; Coronary Disease
• Interventions: Diagnostic Test: Blood serum Neuron-specific Enolase measurement

• Registration Number: NCT04734587
• Lead Sponsor: Ondokuz Mayıs University

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.

Study Timeline

• Study Start: 2019-01-18
• Primary Completion: 2020-03-25
• Study Completion: 2020-03-25
• Study First Submitted: 2021-01-23
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-02
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Chronic Total Occlusion	Blood serum Neuron-specific Enolase measurement	Non-Chronic total occlusion patients undergoing percutaneous coronary intervention.
Chronic Total Occlusion	Blood serum Neuron-specific Enolase measurement	Chronic total occlusion patients undergoing percutaneous coronary intervention.

Primary Outcome Measures

Name	Time	Method
Baseline Neuron-specific Enolase (NSE) measurement	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	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.

Trial Locations

Locations (1)

Ondokuzmayis University; 🇹🇷 Samsun, Turkey