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Without Cerebral perfusıon Under Deep Hypothermic Circulatory Arrest (DHCA) (18 Deegres) the Comparison of the Undergoing Proximal Aortic Surgery Patients Preoperative and Postoperative Diffusion Magnetic Resonance Imaging's and Neuron Specific Enolase Enzyms Levels. (NON)

Primary Purpose

Cerebral Infarct, Neurological Morbidity, Neurological Complication

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
DHCA
Sponsored by
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cerebral Infarct

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with ascending aorta and aortic root aneurysm.
  • 18-85 years old

Exclusion Criteria:

  • 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.

Sites / Locations

  • Dr. Siyami Ersek Thoracic And Cardiovascular Surgery Training And Research Hospital.Recruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

undergoing deep hypothermic cırculatory arrest patients

Arm Description

Difüsıon magnetic rezonans imaging , neuron spesific enolase enzym level , deep hypotermic cırculatory arrest

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 28, 2021
Last Updated
May 7, 2022
Sponsor
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04755439
Brief Title
Without Cerebral perfusıon Under Deep Hypothermic Circulatory Arrest (DHCA) (18 Deegres) the Comparison of the Undergoing Proximal Aortic Surgery Patients Preoperative and Postoperative Diffusion Magnetic Resonance Imaging's and Neuron Specific Enolase Enzyms Levels.
Acronym
NON
Official Title
Without Cerebral perfusıon Under Deep Hypothermic Circulatory Arrest (DHCA) (18 Deegres) the Comparison of the Undergoing Proximal Aortic Surgery Patients Preoperative and Postoperative Diffusion Magnetic Resonance Imaging's and Neuron Specific Enolase Enzyms Levels
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
December 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarct, Neurological Morbidity, Neurological Complication

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single center prospektif clinical research
Masking
None (Open Label)
Masking Description
non
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
undergoing deep hypothermic cırculatory arrest patients
Arm Type
Other
Arm Description
Difüsıon magnetic rezonans imaging , neuron spesific enolase enzym level , deep hypotermic cırculatory arrest
Intervention Type
Procedure
Intervention Name(s)
DHCA
Intervention Description
DHCA THE USE OF SEREBRAL PROTECTİON TECHNİQUE
Primary Outcome Measure Information:
Title
Measuring postoperative changes in cranial diffusion MR imaging.
Description
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.
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
Secondary Outcome Measure Information:
Title
the comparison of the preoperative and postoperative neuron spesific enolase enzyms level.
Description
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.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ascending aorta and aortic root aneurysm. 18-85 years old Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Burak Bozkurt, M.D
Phone
(+90)5541626795
Email
drburakbozkurtt@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Kaplan, Prof. Dr
Organizational Affiliation
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Siyami Ersek Thoracic And Cardiovascular Surgery Training And Research Hospital.
City
Istanbul
State/Province
Üsküdar/ Selimiye
ZIP/Postal Code
34668
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Burak Bozkurt, M.D
Phone
(+90)5541626795
Email
drburakbozkurtt@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
starting 6 months after publication).
IPD Sharing Time Frame
starting 6 months after publication).
IPD Sharing Access Criteria
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code

Learn more about this trial

Without Cerebral perfusıon Under Deep Hypothermic Circulatory Arrest (DHCA) (18 Deegres) the Comparison of the Undergoing Proximal Aortic Surgery Patients Preoperative and Postoperative Diffusion Magnetic Resonance Imaging's and Neuron Specific Enolase Enzyms Levels.

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