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

September 29, 2021 updated by: Muhammet Uyanik, Ondokuz Mayıs University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey
        • Ondokuzmayis University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
NSE blood levels were measured 1-2 hours before the procedure.
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.
12-18 hours after percutaneous coronary intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ondokuz Mayıs University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 18, 2019

Primary Completion (ACTUAL)

March 25, 2020

Study Completion (ACTUAL)

March 25, 2020

Study Registration Dates

First Submitted

January 23, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (ACTUAL)

February 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 6, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBI IN CTO INTERVENTION

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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