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

NCT04734587 | Completed

• 1 other identifier: SBI IN CTO INTERVENTION
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Silent Stroke; Coronary Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

• 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

Study Arms (2)

Chronic Total Occlusion

Chronic total occlusion patients undergoing percutaneous coronary intervention.

Diagnostic Test: Blood serum Neuron-specific Enolase measurement

Non-Chronic Total Occlusion

Non-Chronic total occlusion patients undergoing percutaneous coronary intervention.

Diagnostic Test: Blood serum Neuron-specific Enolase measurement

Interventions

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.

Chronic Total Occlusion; Non-Chronic Total Occlusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who were planned to have revascularization due to CTO in at least one coronary artery (CTO Group) and patients who were scheduled for single-vessel elective coronary intervention other than CTO were defined as Non-CTO (control group).

You may qualify if:

• CTO and Non-CTO patients undergoing percutaneous coronary intervention

You may not qualify if:

• 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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuzmayis University

Samsun, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood serum

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Muhammet Uyanık, M.D.

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: February 2, 2021
• Study Start: January 18, 2019
• Primary Completion: March 25, 2020
• Study Completion: March 25, 2020
• Last Updated: October 6, 2021

Record last verified: 2021-09

Locations

TU (1)