Silent StrokeNCT04734587
Evaluation of Brain Damage Due to Coronary Angioplasty in Percutaneous Intervention Patients
An observational study of Silent Stroke and Coronary Disease, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Silent Stroke, Coronary Disease
- What is being tested?
- Blood serum Neuron-specific Enolase measurement
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2019to 25 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- CTO and Non-CTO patients undergoing percutaneous coronary intervention
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Silent Stroke, Coronary Disease
- Being tested
- Blood serum Neuron-specific Enolase measurement
- Keywords
- silent brain injury, chronic total occlusion, percutaneous coronary intervention, Neuron specific enolase
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood serum Neuron-specific Enolase measurementDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Total Occlusion | Chronic total occlusion patients undergoing percutaneous coronary intervention. Receives: Diagnostic Test: Blood serum Neuron-specific Enolase measurement | |
| Non-Chronic Total Occlusion | Non-Chronic total occlusion patients undergoing percutaneous coronary intervention. Receives: Diagnostic Test: Blood serum Neuron-specific Enolase measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12-18 hours after percutaneous coronary intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start18 Jan 2019
- Primary completion25 Mar 2020
- Study completion25 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Silent StrokeStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammet Uyanik, Ondokuz Mayıs University
- Investigators
- Muhammet Uyanık, M.D., Principal investigator, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734587
- Sponsor's protocol ID
- SBI IN CTO INTERVENTION
- Status last verified
- Sep 2021
- First submitted
- 23 Jan 2021
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Silent Brain Injury in Chronic Total Occlusion Patients With Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT04734587
- Acronym / sponsor ID
- SBI IN CTO INTERVENTION
- Conditions
- Silent Stroke, Coronary Disease
- Keywords
- silent brain injury, chronic total occlusion, percutaneous coronary intervention, Neuron specific enolase
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 25 Mar 2020 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Total Occlusion | – | Diagnostic Test: Blood serum Neuron-specific Enolase measurementChronic total occlusion patients undergoing percutaneous coronary intervention. |
| Non-Chronic Total Occlusion | – | Diagnostic Test: Blood serum Neuron-specific Enolase measurementNon-Chronic total occlusion patients undergoing percutaneous coronary intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- CTO and Non-CTO patients undergoing percutaneous coronary intervention
Key exclusion criteria (7 listed)
- baseline NSE elevation
- acute coronary syndromes or cardiac surgery within 4 weeks
- patients with a cerebrovascular accident
- intracranial hemorrhage
- and head trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood serum Neuron-specific Enolase measurementThe 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. | Diagnostic test | Chronic Total Occlusion, Non-Chronic Total Occlusion |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammet Uyanık, M.D. principal investigator
Ondokuz Mayıs University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Silent Stroke and Coronary Disease, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline Neuron-specific Enolase (NSE) measurement (time frame: NSE blood levels were measured 1-2 hours before the procedure.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2021.