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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04734587
Enrollment
120
Registered
2021-02-02
Start date
2019-01-18
Completion date
2020-03-25
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease, Silent Stroke

Keywords

silent brain injury, chronic total occlusion, percutaneous coronary intervention, Neuron specific enolase

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.

Interventions

DIAGNOSTIC_TESTBlood 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.

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Baseline Neuron-specific Enolase (NSE) measurementNSE 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 diagnosis12-18 hours after percutaneous coronary interventionNSE blood levels were measured 12-18 hours after the procedure. Elevation of \>20 ng/ml was considered as SBI.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026