NON: 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.

Sponsor
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04755439
Collaborator
(none)
32
1
1
60
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: DHCA
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single center prospektif clinical researchSingle center prospektif clinical research
Masking:
None (Open Label)
Masking Description:
non
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Dec 10, 2020
Anticipated Primary Completion Date :
Dec 10, 2023
Anticipated Study Completion Date :
Dec 10, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: undergoing deep hypothermic cırculatory arrest patients

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

Procedure: DHCA
DHCA THE USE OF SEREBRAL PROTECTİON TECHNİQUE

Outcome Measures

Primary Outcome Measures

  1. Measuring postoperative changes in cranial diffusion MR imaging. [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.

Secondary Outcome Measures

  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 (up to 6-36 hours).]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr. Siyami Ersek Thoracic And Cardiovascular Surgery Training And Research Hospital. Istanbul Üsküdar/ Selimiye Turkey 34668

Sponsors and Collaborators

  • Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Investigators

  • Principal Investigator: Mehmet Kaplan, Prof. Dr, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Burak Bozkurt, Principal Investigator,, Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04755439
Other Study ID Numbers:
  • 2020/KK / 239
First Posted:
Feb 16, 2021
Last Update Posted:
May 10, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 10, 2022