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NCT04734587 Clinical Trial

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

Coronary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04734587
Other study ID # SBI IN CTO INTERVENTION
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 18, 2019
Est. completion date March 25, 2020

Study information
Verified date September 2021
Source Ondokuzmayis University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date March 25, 2020
Est. primary completion date March 25, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood serum Neuron-specific Enolase measurement
The Silent Brain Injury ratio was compared by measuring the Neuron-specific enzyme level with venous blood sampling from both patient groups before and after percutaneous coronary intervention.

Locations
Country Name City State
Turkey Ondokuzmayis University Samsun

Sponsors (1)
Lead Sponsor Collaborator
Ondokuzmayis University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Baseline Neuron-specific Enolase (NSE) measurement 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. NSE blood levels were measured 1-2 hours before the procedure.
Primary Silent Brain Injury diagnosis NSE blood levels were measured 12-18 hours after the procedure. Elevation of >20 ng/ml was considered as SBI. 12-18 hours after percutaneous coronary intervention
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