Clinical Trials Directory

Trials / Completed

CompletedNCT04755439

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
35 (actual)
Sponsor
Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
PROCEDUREDHCADHCA THE USE OF SEREBRAL PROTECTİON TECHNİQUE

Timeline

Start date
2020-12-10
Primary completion
2024-01-01
Completion
2025-01-30
First posted
2021-02-16
Last updated
2025-05-30

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04755439. Inclusion in this directory is not an endorsement.