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

Sponsor
Ondokuz Mayıs University (Other)
Overall Status
Completed
CT.gov ID
NCT04734587
Collaborator
(none)
120
1
14.2
8.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood serum Neuron-specific Enolase measurement

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 Design

Study Type:
Observational
Actual Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Assessment of Silent Brain Injury in Chronic Total Occlusion Patients With Percutaneous Coronary Intervention
Actual Study Start Date :
Jan 18, 2019
Actual Primary Completion Date :
Mar 25, 2020
Actual Study Completion Date :
Mar 25, 2020

Arms and Interventions

Arm Intervention/Treatment
Chronic Total Occlusion

Chronic total occlusion patients undergoing percutaneous coronary 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.

Non-Chronic Total Occlusion

Non-Chronic total occlusion patients undergoing percutaneous coronary 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ondokuzmayis University Samsun Turkey

Sponsors and Collaborators

  • Ondokuz Mayıs University

Investigators

  • Principal Investigator: Muhammet Uyanık, M.D., Ondokuz Mayıs University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Muhammet Uyanik, Principal Investigator, Ondokuz Mayıs University
ClinicalTrials.gov Identifier:
NCT04734587
Other Study ID Numbers:
  • SBI IN CTO INTERVENTION
First Posted:
Feb 2, 2021
Last Update Posted:
Oct 6, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Muhammet Uyanik, Principal Investigator, Ondokuz Mayıs University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 6, 2021