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Ascending Aortic AneurysmNCT05839990

Biomechanical Properties of the Human Ascending Aortic Wall in Aneurysm

A study testing Surgery in people with Ascending Aortic Aneurysm, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 17 to 80 years
Conditions the study is for
Ascending Aortic Aneurysm
What is being tested?
Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteRussia
Study dates
21 Mar 2022to 1 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 17 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Ascending aortic aneurysm (50 mm and more)
  • Ascending aortic dilatation (45-49 mm)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site
  • Tomsk NRMC

    Tomsk, 634012

Other trials in Russia

About this study

Official title: Biomechanical and Elastic Properties of the Ascending Wall of the Human Aorta in Aneurysm

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

Read the 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.

Being tested
Surgery
Medical subject headings
Aneurysm, Ascending Aorta

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    Also called Surgical treatment

    Replacement of the ascending aorta in case of anerysm and dilatation

Study groups in NCT05839990
Study groupRoleWhat they receive
SurgeryActive comparatorPatients with ascending aortic aneurysm and dlatation who undergo surgical tretment
Receives: Procedure: Surgery
Non-surgeryNo interventionPatients with ascending aortic dlatation who undergo surveillance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. mortality

    assess early and late death cases in aneurysm and dilatation groups in operated and nonoperarted patients

    Measured: up to 5 years

  2. aortic growth

    assess of the aortic growth in mm during foloow up in nonoperated patients

    Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start21 Mar 2022
  3. Primary completion21 Mar 2022
  4. Study completion1 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05839990
Sponsor's protocol ID
CRI-205/2
Status last verified
Jun 2026
First submitted
21 Apr 2023
Last updated
24 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Surgery in people with Ascending Aortic Aneurysm, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mortality (time frame: up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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