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Completed

NCT Number: NCT04734587

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

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.

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Key information

Conditions

Silent Stroke Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ondokuzmayis University

Samsun, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood serum Neuron-specific Enolase measurement

Diagnostic Test

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 2, 2021
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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