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Biomechanical Properties of the Human Ascending Aortic Wall in Aneurysm

Primary Purpose

Ascending Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Surgery
Sponsored by
Tomsk National Research Medical Center of the Russian Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ascending Aortic Aneurysm

Eligibility Criteria

17 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ascending aortic aneurysm (50 mm and more) Ascending aortic dilatation (45-49 mm) Exclusion Criteria: Aortic dissection Patients with known/documented coagulopathy Oncological disease (high degrees) Severe chronic heart failure Refusal of surgical treatment Patients in renal failure or currently being treated with renal replacement therapy (RRT) or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 Severe carotid disease, defined as: any patient with previously documented carotid stenosis of > 70%, without neurological deficits; or carotid stenosis > 50% with neurological deficits; or previous carotid endarterectomy or stenting Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon

Sites / Locations

  • Tomsk NRMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Surgery

Non-surgery

Arm Description

Patients with ascending aortic aneurysm and dlatation who undergo surgical tretment

Patients with ascending aortic dlatation who undergo surveillance

Outcomes

Primary Outcome Measures

mortality
assess early and late death cases in aneurysm and dilatation groups in operated and nonoperarted patients
aortic growth
assess of the aortic growth in mm during foloow up in nonoperated patients

Secondary Outcome Measures

Full Information

First Posted
April 21, 2023
Last Updated
October 18, 2023
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05839990
Brief Title
Biomechanical Properties of the Human Ascending Aortic Wall in Aneurysm
Official Title
Biomechanical and Elastic Properties of the Ascending Wall of the Human Aorta in Aneurysm
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
March 21, 2022 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences

4. Oversight

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

5. Study Description

Brief Summary
The aim of the study is to analyze the efficacy of the surgical tretment in patients with ascending aortic aneurysm and dilatation. And to assess rate of negative clinical scenarios in non-oparated patients with ascending aortic dilatation
Detailed Description
Description of the procedures: All surgical procedures will be performed via median sternotomy. During the aortic arch anastomosis, continuous, unilateral SACP using innominate artery will be employed. Unilateral SACP may be converted to bilateral ACP at the surgeon's discretion if adequate cerebral flows are not achieved or if there are concerns with cerebral oximetry measurements. Once on CPB, the patient will be cooled to a nasopharyngeal (NP) temperature of 28-30 °C. Rectal temperature with be monitored as an additional temperature sites. Unilateral SACP will only be initiated once the target temperature has been reached. SACP via the innominate artery will be commenced with target flows of 8-10 ml/kg/min and perfusion pressure of 60-80 mmHg. Perfusion adequacy will be evaluated using measurement of blood pressure in both radial arteries and cerebral oximetry using near-infrared spectroscopy (NIRS). After completion of the aortic hemiarch replacement, CPB will be resumed and the patient re-warmed to 36 °C prior to coming off CPB, with a = 1 °C temperature difference between temperature monitoring sites (NP and rectal). Intraoperative information will be collected from the anesthetic record, surgical notes and perfusion records. Intraoperative data collection will include total operative time, CPB time, cross-clamp time, hypothermic cardiac arrest time, uSACP time, lowest nasopharyngeal and rectal temperature, arterial pressure in both radial arteries, perfusion rate and perfusion pressure during both of CPB and unilateral SACP, lowest hemoglobin concentration (g/L) and hematocrit (%), acid-base indices, intraoperative red blood cell transfusion (units), highest dose/agent used for intraoperative inotrope or vasopressor support. Also during the surgery will be performed NIRS and BIS-monitoring. Postoperative data will include valuation of following indicators: mortality (hospital mortality and death from any cause); neurological injury (TIA, stroke, delirium), MRI and CT-scan only in event of postoperative stroke; acute kidney injury (creatinine level prior and 1, 2, 4 postoperative day (POD), urine output-up to 24-48 h, renal replacement therapy (dialysis); time of mechanical ventilation; re-exploration for bleeding, tamponade or other reasons; postoperative transfusion (packed red blood cells, platelets, fresh frozen platelets, cryoprecipitate); postoperative myocardial infarction (electrocardiogram and troponins); inotropic support during 24-48 h (agent and dose (VIS)); length of stay (intensive care unit and total hospital days). In non-operted grop of patients annually echo cardiography, CT scans will be performed. Aortic imaging All measurements will be taken using electrocardiography-gated computed tomographic angiography. Analysis was 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. Adopted computed tomographic protocol included unenhanced, arterial, and delayed data acquisition. The arterial phase will be acquired after intravenous injection of 80-100 mL of nonionic iodinated contrast at 5 mL/s, followed by a 50-mL bolus of saline solution. Delayed-phase scans will be obtained 120-180 seconds after contrast injection. All measurements will be taken in multiplanar reconstruction, 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. Normalized aortic diameter (cm/m2) will be calculated by dividing the maximum aortic diameter (cm) by the body surface area (m2). The body surface area will be calculated based on the Mosteller formula: body surface area (m2) = √([Height (cm) x Weight (kg)]/3600). Analysis and assessment of the images will be based on the consensus between two experienced investigators. Follow-up information will be collected using direct or phone contact with patients, relatives, or physicians.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascending Aortic Aneurysm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
Patients with ascending aortic aneurysm and dlatation who undergo surgical tretment
Arm Title
Non-surgery
Arm Type
No Intervention
Arm Description
Patients with ascending aortic dlatation who undergo surveillance
Intervention Type
Procedure
Intervention Name(s)
Surgery
Other Intervention Name(s)
Surgical treatment
Intervention Description
Replacement of the ascending aorta in case of anerysm and dilatation
Primary Outcome Measure Information:
Title
mortality
Description
assess early and late death cases in aneurysm and dilatation groups in operated and nonoperarted patients
Time Frame
up to 5 years
Title
aortic growth
Description
assess of the aortic growth in mm during foloow up in nonoperated patients
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ascending aortic aneurysm (50 mm and more) Ascending aortic dilatation (45-49 mm) Exclusion Criteria: Aortic dissection Patients with known/documented coagulopathy Oncological disease (high degrees) Severe chronic heart failure Refusal of surgical treatment Patients in renal failure or currently being treated with renal replacement therapy (RRT) or estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 Severe carotid disease, defined as: any patient with previously documented carotid stenosis of > 70%, without neurological deficits; or carotid stenosis > 50% with neurological deficits; or previous carotid endarterectomy or stenting Pre-existing severe neurological impairment or inability to accurately assess neurocognitive function as determined by the operating surgeon
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitry S Panfilov, PhD, MD
Organizational Affiliation
Cardiology Research Institute, Tomsk National Research Medic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tomsk NRMC
City
Tomsk
ZIP/Postal Code
634012
Country
Russian Federation

12. IPD Sharing Statement

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Biomechanical Properties of the Human Ascending Aortic Wall in Aneurysm

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