Ascending Aortic AneurysmNCT04905225
The Gender Specific Effect on the Results of Ascending Aortic Replacement
An observational study of Ascending Aortic Aneurysm, run by Tomsk National Research Medical Center of the Russian Academy of Sciences at 1 site in Russia.
Trial summary
The aim of our study is to analyze the early and late results in men and women who underwent ascending aortic replacement in antegrade cerebral perfusion (ACP) with mild-to-moderate hypothermic circulatory arrest. Female gender is associated with poorer outcomes after surgical aorta replacement. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ascending Aortic Aneurysm
- What is being tested?
- Ascending aortic replacement
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2013to 1 Jul 2023
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ascending aortic aneurysm with Hemiarch replacement
Who may be able to join
- Patients with small ascending aortic aneurysm (5.0-5.5 cm)
- Elective procedure
- Able to provide written informed consent
Who cannot join
- Surgery for acute aortic dissection or emergent operations
- Refusal of surgical treatment
- Oncological disease (high degrees)
- Multiple organ failure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Gender Specific Effect on the Results of Ascending Aortic Replacement in Small Ascending Aortic Aneurysm
The aim of our study is to analyze the early and late results in men and women who underwent ascending aortic replacement in antegrade cerebral perfusion (ACP) with mild-to-moderate hypothermic circulatory arrest. Female gender is associated with poorer outcomes after surgical aorta replacement. Data on gender specific differences after ascending aortic replacement are conflicting.
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 either 26-32 °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(bispectral index).
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), 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); length of stay (intensive care unit and total hospital days).
Follow-up information will be collected using direct or phone contact with patients, relatives, or physicians.
- Conditions
- Ascending Aortic Aneurysm
- Being tested
- Ascending aortic replacement
- 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.
Ascending aortic replacementProcedure or surgery
Surgical access will be performed through a median sternotomy. Ascending aortic repair is performed under conditions of cardiopulmonary bypass (CPB) and MHCA with unilateral ACP via innominate artery with a flow rate of 8-10 ml/kg/min and perfusion pressure of 60-80 mmHg. Once CPB is instituted, the aortic cross-clamp is applied, and the heart is arrested with antegrade cardioplegia. Hemiarch replacement involves resection lesser curve of the aortic arch from the base of the innominate artery (Zone 0) to a point immediately distal to the nadir of the lesser curvature (Zone 3 or Zone 2 if the left subclavian artery was too far).
| Study group | Role | What they receive |
|---|---|---|
| Ascending aortic replacement | Ascending aortic replacement in ascending aortic aneurysm in men and women Receives: Procedure: Ascending aortic replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative mortality
Operative mortality (%) as assessed by data linkage to medical records Comparison of men vs women in aortic hemiarch surgery with respect to the incidence of death
Measured: During the first 30 days after the procedure
All-cause mortality
all-cause mortality as assessed by data linkage to medical records or or phone contact with relatives or physicians
Measured: Up to 5 years
Secondary outcomes (6)
Perioperative Myocardial Infarction
Incidence of the myocardial infarction (%) is assessed by complex evaluation based on the ECG and echocardiographic changes as well as increase of the troponin level using serum assay
Measured: During the first 30 days after the procedure (assessed by daily serum assay and ECG in the ICU and every 5 days after discharge from ICU. )
Rates of re-exploration for bleeding
Percentage of patients requiring re-exploration for bleeding.
Measured: During the first 3 days after the procedure
Respiratory failure
Percentage of patients requiring prolonged lung ventilation (> 72 hours) or tracheostomy
Measured: During the first 30 days after the procedure
The duration of a patient's stay in the intensive care unit and on the hospital ward
The duration of a patient's stay in the intensive care unit and on the hospital ward
Measured: Up to 90 days after surgery
Incidence of Acute Kidney Injury (AKI)
Percentage of patients requiring renal replacement therapy (i.e. haemodialysis or haemofiltration
Measured: During the first 30 days after the procedure
Composite of neurologic injury
Percentage of patients with neurological complications is assessed. Single assessment by CT or MRI. More often if necessary.
Measured: During the first 30 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start1 Jan 2013
- Primary completion1 Jun 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascending Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris N Kozlov, Dr, Study director, TOMSK NRMC CARDIOLOGY RESEARCH INSTITUTE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905225
- Sponsor's protocol ID
- CRI-205
- Status last verified
- Jun 2026
- First submitted
- 23 May 2021
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Gender Specific Effect on the Results of Ascending Aortic Replacement in Small Ascending Aortic Aneurysm
- ClinicalTrials.gov ID
- NCT04905225
- Acronym / sponsor ID
- CRI-205
- Conditions
- Ascending Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tomsk National Research Medical Center of the Russian Academy of SciencesUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of our study is to analyze the early and late results in men and women who underwent ascending aortic replacement in antegrade cerebral perfusion (ACP) with mild-to-moderate hypothermic circulatory arrest. Female gender is associated with poorer outcomes after surgical aorta replacement. Data on gender specific differences after ascending aortic replacement are conflicting.
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 either 26-32 °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(bispectral index).
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), 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); length of stay (intensive care unit and total hospital days).
Follow-up information will be collected using direct or phone contact with patients, relatives, or physicians.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ascending aortic replacement | – | Procedure: Ascending aortic replacementAscending aortic replacement in ascending aortic aneurysm in men and women |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ascending aortic aneurysm with Hemiarch replacement
Key inclusion criteria (3 listed)
- Patients with small ascending aortic aneurysm (5.0-5.5 cm)
- Elective procedure
- Able to provide written informed consent
Key exclusion criteria (4 listed)
- Surgery for acute aortic dissection or emergent operations
- Refusal of surgical treatment
- Oncological disease (high degrees)
- Multiple organ failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ascending aortic replacementSurgical access will be performed through a median sternotomy. Ascending aortic repair is performed under conditions of cardiopulmonary bypass (CPB) and MHCA with unilateral ACP via innominate artery with a flow rate of 8-10 ml/kg/min and perfusion pressure of 60-80 mmHg. Once CPB is instituted, the aortic cross-clamp is applied, and the heart is arrested with antegrade cardioplegia. Hemiarch replacement involves resection lesser curve of the aortic arch from the base of the innominate artery (Zone 0) to a point immediately distal to the nadir of the lesser curvature (Zone 3 or Zone 2 if the left subclavian artery was too far). | Procedure or surgery | Ascending aortic replacement |
Primary outcome
Operative mortality
Time frame: During the first 30 days after the procedure
Operative mortality (%) as assessed by data linkage to medical records Comparison of men vs women in aortic hemiarch surgery with respect to the incidence of death
All-cause mortality
Time frame: Up to 5 years
all-cause mortality as assessed by data linkage to medical records or or phone contact with relatives or physicians
6 secondary outcomes
Perioperative Myocardial Infarction
Time frame: During the first 30 days after the procedure (assessed by daily serum assay and ECG in the ICU and every 5 days after discharge from ICU. )
Rates of re-exploration for bleeding
Time frame: During the first 3 days after the procedure
Respiratory failure
Time frame: During the first 30 days after the procedure
The duration of a patient's stay in the intensive care unit and on the hospital ward
Time frame: Up to 90 days after surgery
Incidence of Acute Kidney Injury (AKI)
Time frame: During the first 30 days after the procedure
Composite of neurologic injury
Time frame: During the first 30 days after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Related trials for Ascending Aortic Aneurysm
Recruiting
Treatment in Thoracic Aortic Aneurysm: Surgery vs Surveillance
Ascending Aortic Aneurysm Enlargement, Ascending Aorta Aneurysm
Active, not recruiting
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
Aortic Dissection
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm
Enrolling by invitationObservational study
Bicuspid Aortic Valve (BAV) Registry
Bicuspid Aortic Valve
Not yet recruiting
Selective Antegrade Cerebral Perfusion and Perioperative Optic Nerve Sheath Diameter in Ascending Aortic Surgery
Aortic Diseases, Cardiac Surgical Procedures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris N Kozlov, Dr study director
TOMSK NRMC CARDIOLOGY RESEARCH INSTITUTE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 inclusion and 4 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?
Operative mortality (time frame: During the first 30 days after the procedure). 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.