Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences, Tomsk, Russia
Tomsk, 634012, Russia
Location status: Recruiting
NCT Number: NCT07386028
This study investigates outcomes after hemiarch repair in patients with chronic ascending aortic disease. The patients will be divided into two groups according to surgical approach: 100 patients will undergo hemiarch repair via full sternotomy (FS group) and 100 patients will receive hemiarch repair via J-shaped mini-sternotomy (MS group). Early and late outcomes will be recorded.
Interested in participating?
Request Info18 year–80 year
All sexes
Interventional
Not applicable
Tomsk, 634012, Russia
Location status: Recruiting
Imaging All aortic measurements will be assessed by electrocardiography-gated computed tomographic angiography. Postoperative computed tomography of the aorta will be performed within 2 weeks after surgery. Analysis will be performed using 64-slice scanner Discovery NM-CT 570c (GE Healthcare, Milwaukee, WI, USA) with spatial resolution of the angiographic phase ranging from 0.6 to 1.25 mm. All measurements will be taken always in the plane perpendicular to the manually corrected local aortic centre line. Ascending aortic diameter will be measured at the level of the pulmonary artery bifurcation. The maximum aortic diameter (mm) will be measured from the outer contours of the aortic wall. All images will be independently assessed by two experienced cardiologists.
Surgical technique The hemiarch repair is performed via a full sternotomy or J-shaped mini-sternotomy under mild-to-moderate hypothermia (28-30°C) and antegrade cerebral perfusion through the innominate artery with side graft. The distal aortic anastomosis is performed using an open anastomosis fashion and involved resection of the inferior portion of the aortic arch from the base of the innominate artery to the projection of the origin of the left subclavian artery. Near infrared spectroscopy (Invos 5100, Somanetics Corp., USA) is used for cerebral monitoring during the operation. When the target temperature is achieved, lower body circulatory arrest with antegrade cerebral perfusion is initiated. The distal aortic anastomosis is performed with a running 4/0 polypropylene suture with a Dacron graft. Proximal aortic reconstruction including Bentall procedure, David procedure, proximal aortic anastomosis, etc. are performed during the rewarming period. The patient is weaned from cardiopulmonary bypass when the body temperature reached 36°C. The sequence of the surgical steps during the operation are the same for all patients.
Follow-up Follow-up will be performed according to the institutional database supplemented by individual patient records. Data will be obtained via medical records of clinical encounters or phone calls with patients and/or relatives. Postoperative computed tomographic scans will be performed upon discharge, at 12 months from the last procedure and at 60 months thereafter.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
hemiarch repair via full sternotomy
hemiarch repair via J-shaped mini-sternotomy
Time frame: during follow-up time - 60 months
The difference in the incidence of early mortality between groups (p-value).
Time frame: Perioperative/Periprocedural
The difference in the incidence of delirium during follow-up (p-value).
Time frame: Perioperative/Periprocedural
The difference in the incidence of transient ischemic attack during follow-up (p-value).
Time frame: during follow-up time - 60 months
The difference in the incidence of stroke during follow-up (p-value).
Time frame: Perioperative/Periprocedural
The difference in the incidence of respiratory failure during follow-up (p-value).
Time frame: during follow-up time - 60 months
The difference in the incidence of new arrythmia during follow-up (p-value).
Time frame: Perioperative/Periprocedural
The difference in the incidence of new arrythmia during follow-up (p-value).
Time frame: during follow-up time - 60 months
The difference in the incidence of heart failure during follow-up (p-value).
Time frame: during follow-up time - 60 months
The difference in the incidence of myocardial infarction during follow-up (p-value).
Time frame: during follow-up time - 60 months
The difference in the incidence of systemic embolism during follow-up (p-value).
Time frame: during follow-up time - 60 months
The difference in the incidence of renal replacement therapy during follow-up (p-value).
Time frame: during follow-up time - 60 months
The difference in the incidence of re-operation for bleeding during follow-up (p-value).
Contact information is provided by the study sponsor or research team.
Andrey V. Sofronov
CONTACT
Dmitri S. Panfilov, MD, PhD
CONTACT
Tomsk Cardiology Research Institute
Other
Full Sternotomy Versus J-shaped Mini-sternotomy for Chronic Ascending Aortic Pathology
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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