Cerebral InfarctNONNCT04755439
Evaluation of Cerebral Parenchymal Changes in Patients Undergoing Proximal Aortic Surgery With Deep Hypothermic Circulatory Arrest Using Diffusion MRI
A study testing DHCA in people with Cerebral Infarct and Neurological Morbidity, run by Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Deep hypothermic circulatory arrest (DHCA) (18 degree) without cerebral perfusion is a safe technique. Resarchers use this technique in patients with proximal aortic pathologies. During the DHCA period, cerebral silent ischemic events may occur. But the silent ischemic events don't neurological problems with patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cerebral Infarct, Neurological Morbidity, Neurological Complication
- What is being tested?
- DHCA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2020to 30 Jan 2025
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ascending aorta and aortic root aneurysm.
- 18-85 years old
Who cannot join
- Patients without ascending aortic and aortic root aneurysms
- outside the age range of 18-85, emergency surgery,
- Exceeding the magnetic resonance imaging extraction time limit.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Siyami Ersek Thoracic And Cardiovascular Surgery Training And Research Hospital.
Istanbul, Üsküdar/ Selimiye, 34668
About this study
Official title: Evaluation of Cerebral Parenchymal Changes in Patients Undergoing Proximal Aortic Surgery With Deep Hypothermic Circulatory Arrest Using Diffusion MR
Deep hypothermic circulatory arrest (DHCA) (18 degree) without cerebral perfusion is a safe technique. Resarchers use this technique in patients with proximal aortic pathologies.
During the DHCA period, cerebral silent ischemic events may occur. But the silent ischemic events don't neurological problems with patients.
Read the detailed description
It is important to evaluate neurological functions in patients with ascending aortic and aortic root aneurysms who underwent deep hypothermic circulatory arrest (18 degrees) and did not undergo cerebral perfusion. However, neurological changes that are reflected in the clinic are not always encountered. Using preoperative and postoperative diffusion magnetic resonance imaging, silent ischemic lesions that are not reflected in the clinic can be detected. Although there are studies using DW-MRI in patients undergoing different cerebral protection methods in the literature, there are no studies conducted on patients who underwent deep hypothermic circulatory arrest without cerebral perfusion.
To detect silent ischemic lesions with preoperative and postoperative diffusion magnetic resonance method in patients with ascending aortic and aortic root aneurysms undergoing deep hypothermic circulatory arrest (18 degrees) and without cerebral perfusion, and to investigate the correlation between preoperative and postoperative neuron-specific enolase levels and serbral findings.
Cerebral ischemic lesions that may occur in patients undergoing deep hypothermic circulatory arrest (18 degrees) and undergoing ascending aortic and aortic root aneurysm surgery without cerebral perfusion will be detected, and the clinical follow-up and treatment of the patients will be better managed.
We base the imaging of diffusion MR among the examinations to be performed on literature studies that show that withdrawal of patients in the early postoperative period (3rd-7th days) due to the surgical method to be performed without cerebral perfusion under deep hypothermic circulatory arrest, increases the specificity and sensitivity of the test. Therefore, the application of diffusion MR imaging in the early postoperative period (3rd-7th days) after a surgical technique performed under deep hypothermic circulatory arrest (18 degrees) without cerebral perfusion constitutes an indication for diffusion MR in order to detect cerebral ischemic lesions in the early period. Therefore, diffusion MR imaging to be taken in the early period (3rd-7th days) will provide us with the opportunity to create an effective algorithm in terms of patient treatment and follow-up.
- Being tested
- DHCA
- Medical subject headings
- Cerebral Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHCAProcedure or surgery
DHCA THE USE OF SEREBRAL PROTECTİON TECHNİQUE
| Study group | Role | What they receive |
|---|---|---|
| undergoing deep hypothermic cırculatory arrest patients | Other | Difüsıon magnetic rezonans imaging , neuron spesific enolase enzym level , deep hypotermic cırculatory arrest Receives: Procedure: DHCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring postoperative changes in cranial diffusion MR imaging.
Changes due to new ischemia or hypoperfusion in the cerebral and cerebellar hemispheres will be measured in terms of volume(cm square or mm square). The measurements will be determined using cranial diffusion mr.
Measured: Preoperative (1-3 days before operation time) and postoperative (until the 7th day) cranial diffusion MR of the patients will be taken and compared
Secondary outcomes (1)
the comparison of the preoperative and postoperative neuron spesific enolase enzyms level.
The neuron-specific enolase levels of the patients will be checked in the morning of the operation and postoperatively (until 6-36 hours). Neuron-specific enolase enzyme levels will be measured from the blood sample.
Measured: The neuron-specific enolase levels of the patients will be checked in the morning of the operation and postoperatively (up to 6-36 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start10 Dec 2020
- Primary completion1 Jan 2024
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral InfarctStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center prospective clinical research
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Bozkurt, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
- Investigators
- Mehmet Kaplan, Prof. Dr, Principal investigator, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755439
- Sponsor's protocol ID
- 2020/KK / 239
- Acronym
- NON
- Status last verified
- May 2025
- First submitted
- 28 Jan 2021
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: starting 6 months after publication).
Publications
Bozkurt B, Akinci O, Kus MK, Oren C, Yildiz Z, Yesilkaya I, Erturk O, Kaplan M. Silent cerebral infarction after proximal thoracic aortic surgery under deep hypothermic circulatory arrest: an exploratory prospective DW-MRI study. BMC Cardiovasc Disord. 2026 Jul 6. doi: 10.1186/s12872-026-06168-y. Online ahead of print.
PubMed 42402559
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cerebral Parenchymal Changes in Patients Undergoing Proximal Aortic Surgery With Deep Hypothermic Circulatory Arrest Using Diffusion MR
- ClinicalTrials.gov ID
- NCT04755439
- Acronym / sponsor ID
- NON / 2020/KK / 239
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 16 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.
Deep hypothermic circulatory arrest (DHCA) (18 degree) without cerebral perfusion is a safe technique. Resarchers use this technique in patients with proximal aortic pathologies.
During the DHCA period, cerebral silent ischemic events may occur. But the silent ischemic events don't neurological problems with patients.
Detailed description
It is important to evaluate neurological functions in patients with ascending aortic and aortic root aneurysms who underwent deep hypothermic circulatory arrest (18 degrees) and did not undergo cerebral perfusion. However, neurological changes that are reflected in the clinic are not always encountered. Using preoperative and postoperative diffusion magnetic resonance imaging, silent ischemic lesions that are not reflected in the clinic can be detected. Although there are studies using DW-MRI in patients undergoing different cerebral protection methods in the literature, there are no studies conducted on patients who underwent deep hypothermic circulatory arrest without cerebral perfusion.
To detect silent ischemic lesions with preoperative and postoperative diffusion magnetic resonance method in patients with ascending aortic and aortic root aneurysms undergoing deep hypothermic circulatory arrest (18 degrees) and without cerebral perfusion, and to investigate the correlation between preoperative and postoperative neuron-specific enolase levels and serbral findings.
Cerebral ischemic lesions that may occur in patients undergoing deep hypothermic circulatory arrest (18 degrees) and undergoing ascending aortic and aortic root aneurysm surgery without cerebral perfusion will be detected, and the clinical follow-up and treatment of the patients will be better managed.
We base the imaging of diffusion MR among the examinations to be performed on literature studies that show that withdrawal of patients in the early postoperative period (3rd-7th days) due to the surgical method to be performed without cerebral perfusion under deep hypothermic circulatory arrest, increases the specificity and sensitivity of the test. Therefore, the application of diffusion MR imaging in the early postoperative period (3rd-7th days) after a surgical technique performed under deep hypothermic circulatory arrest (18 degrees) without cerebral perfusion constitutes an indication for diffusion MR in order to detect cerebral ischemic lesions in the early period. Therefore, diffusion MR imaging to be taken in the early period (3rd-7th days) will provide us with the opportunity to create an effective algorithm in terms of patient treatment and follow-up.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center prospective clinical research
| Arm | Type | Receives |
|---|---|---|
| undergoing deep hypothermic cırculatory arrest patients | Other | Procedure: DHCADifüsıon magnetic rezonans imaging , neuron spesific enolase enzym level , deep hypotermic cırculatory arrest |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with ascending aorta and aortic root aneurysm.
- 18-85 years old
Key exclusion criteria (3 listed)
- Patients without ascending aortic and aortic root aneurysms
- outside the age range of 18-85, emergency surgery,
- Exceeding the magnetic resonance imaging extraction time limit.
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 |
|---|---|---|
| DHCADHCA THE USE OF SEREBRAL PROTECTİON TECHNİQUE | Procedure or surgery | undergoing deep hypothermic cırculatory arrest patients |
Primary outcome
Measuring postoperative changes in cranial diffusion MR imaging.
Time frame: Preoperative (1-3 days before operation time) and postoperative (until the 7th day) cranial diffusion MR of the patients will be taken and compared
Changes due to new ischemia or hypoperfusion in the cerebral and cerebellar hemispheres will be measured in terms of volume(cm square or mm square). The measurements will be determined using cranial diffusion mr.
1 secondary outcome
the comparison of the preoperative and postoperative neuron spesific enolase enzyms level.
Time frame: The neuron-specific enolase levels of the patients will be checked in the morning of the operation and postoperatively (up to 6-36 hours).
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 30 May 2025.
- Derived from this study: PubMed 42402559Bozkurt B, Akinci O, Kus MK, Oren C, Yildiz Z, Yesilkaya I, Erturk O, Kaplan M. Silent cerebral infarction after proximal thoracic aortic surgery under deep hypothermic circulatory arrest: an exploratory prospective DW-MRI study. BMC Cardiovasc Disord. 2026 Jul 6. doi: 10.1186/s12872-026-06168-y. Online ahead of print.
- Individual participant dataSharing planned: Yes. starting 6 months after publication).
Related trials for Cerebral Infarct
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
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.
Mehmet Kaplan, Prof. Dr principal investigator
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DHCA in people with Cerebral Infarct and Neurological Morbidity, run by Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital 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 2 inclusion and 3 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 30 May 2025. 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?
Measuring postoperative changes in cranial diffusion MR imaging. (time frame: Preoperative (1-3 days before operation time) and postoperative (until the 7th day) cranial diffusion MR of the patients will be taken and compared). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755439, which also lists 1 linked publication.
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 30 May 2025.