Evaluation of Cerebral Parenchymal Changes in Patients Undergoing Proximal Aortic Surgery With Deep Hypothermic Circulatory Arrest Using Diffusion MRI

NCT ID: NCT04755439

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2025-01-30

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.

Conditions

Cerebral Infarct; Neurological Morbidity; Neurological Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

undergoing deep hypothermic cırculatory arrest patients

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

Group Type: OTHER

DHCA

Intervention Type: PROCEDURE

DHCA THE USE OF SEREBRAL PROTECTİON TECHNİQUE

Interventions

DHCA

DHCA THE USE OF SEREBRAL PROTECTİON TECHNİQUE

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Burak Bozkurt

Principal Investigator,

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mehmet Kaplan, Prof. Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Istanbul, Üsküdar/ Selimiye, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2020/KK / 239

Identifier Type: -

Identifier Source: org_study_id