Coronary Artery DiseaseNCT07071857
Coronary Artery Bypass Grafting With Ascending Aortic Replacement
A study testing ECG CT angiography, TTFM and computed tomography of the aorta and/or grafts in people with Coronary Artery Disease and Ascending Aortic Aneurysm, run by Tomsk Cardiology Research Institute.
Trial summary
This retrospective study investigates early outcomes after CABG as well as graft patency rate in patients with concomitant AAR. 35 patients undergoing CABG with concomitant AAR (CABG+AAR group) were case-control matched to 35 patients who received isolated CABG (CABG group) in regard to transit-time flow measurement… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Ascending Aortic Aneurysm
- What is being tested?
- ECG CT angiography, TTFM and computed tomography of the aorta and/or grafts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2013to 20 Dec 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years.
- Signed informed consent.
- Severe left main stem artery stenosis, or left main equivalent disease (70% or greater stenosis in diameter of the left anterior descending artery, proximal left circumflex artery and right coronary artery).
- Ascending aorta greater than 5 cm.
Who cannot join
- Dissections or urgent/emergent cases.
- Redo aortic surgery.
- Total aortic arch surgery.
About this study
Official title: Coronary Artery Bypass Grafting With Concomitant Ascending Aortic Replacement: a Case-control Study
This retrospective study investigates early outcomes after CABG as well as graft patency rate in patients with concomitant AAR. 35 patients undergoing CABG with concomitant AAR (CABG+AAR group) were case-control matched to 35 patients who received isolated CABG (CABG group) in regard to transit-time flow measurement (TTFM) findings, early and late outcomes.
Read the detailed description
- Relevance of the study. Coronary artery bypass grafting is an effective treatment for patients with coronary artery disease (CAD). Nowadays, this operation is the most common surgical procedure performed on the heart, with >600,000 operations per year worldwide. Approximately 15-20% of patients with CAD require concomitant cardiac surgery with relatively high incidence of postoperative morbidity and mortality. It is considered that concomitant CAD in patients undergoing thoracic aortic surgery is an independent risk factor for perioperative mortality. Taking into account the recently published data, CABG added to other cardiac surgeries is associated with increased short- and long-term mortality. There are no available data on the relationship between the outcomes of the concomitant CABG and the patency of coronary grafts. The aim of this study was to assess the early outcomes after CABG as well as graft patency rate in patients with concomitant AAR.
- Patients and methods. 35 patients who underwent CABG concomitant with ascending aortic replacement (CABG+AAR group) were compared with 35 patients who underwent isolated CABG (CABG group). Baseline characteristics which included preoperative characteristics, details on surgery (duration of cardiopulmonary bypass, cardioplegic arrest, antegrade cerebral perfusion), and early and late postoperative outcomes were compared between these groups.
Imaging All aortic measurements and postoperative graft patency were assessed by electrocardiography-gated computed tomographic angiography. Postoperative computed tomography of the aorta and/or grafts was performed within 2 weeks after surgery. 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. All measurements were taken always in the plane perpendicular to the manually corrected local aortic centre line. Ascending aortic diameter was measured at the level of the pulmonary artery bifurcation. The maximum aortic diameter (mm) was measured from the outer contours of the aortic wall.
The postoperative graft status was classified according to Fitzgibbon classification where Grade A is a patent graft, grade B is a stenosed graft (<50% of the grafted coronary artery) or a string sign and grade O is an occluded graft. All images were independently assessed by two experienced cardiologists.
Surgical technique CABG surgery was performed in the standard manner with a cardiopulmonary bypass and carioplegic arrest. Left internal mammary arterial (LIMA) grafts were used as in situ grafts to the LAD in all of the cases. All saphenous vein grafts (SVGs) were used in an aortocoronary bypass fashion. Proximal anastomoses were sewn to the aorta/graft with side-biting clamp on the beating heart.
The surgery was performed through a median sternotomy under mild-to-moderate hypothermia (28-30°C) and antegrade cerebral perfusion via the innominate artery with side graft. The distal aortic anastomosis was 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 (hemiarch repair). Near infrared spectroscopy (Invos 5100, Somanetics Corp., USA) was used for cerebral monitoring during the operation. When the target temperature was achieved, lower body circulatory arrest with antegrade cerebral perfusion was initiated. The distal aortic anastomosis was performed with a running 4/0 polypropylene suture with a Dacron graft. Proximal aortic anastomosis as well as coronary artery bypass grafting was performed during the rewarming period. The patient was weaned from cardiopulmonary bypass when the body temperature reached 36°C. The sequence of the surgical steps during the operation was the same for all patients.
Transit time flow measurement Graft flow tracing was recorded intraoperatively after weaning from cardiopulmonary bypass and just before sternal closure with a transit-time flowmeter (VQ1001, Medi-Stim AS, Oslo, Norway). The haemodynamic condition remained stable with a mean blood pressure between 70 and 90 mmHg during the flow measurement. The device displays a flow curve and calculates the mean graft flow (MGF) (ml/min), pulsatile index (PI) and diastolic filling percentage (DF%). The TTFM criteria for graft revision were MGF of <5 ml/min, PI of >5 or DF ratio of <50%.
Follow-up Follow-up was performed according to the institutional database supplemented by individual patient records. Data was obtained via medical records of clinical encounters or phone calls with patients and/or relatives. Postoperative computed tomographic scans and angiograms were performed upon discharge, at 12 months from the last procedure and annually thereafter.
- Conditions
- Coronary Artery Disease, Ascending Aortic Aneurysm
- Being tested
- ECG CT angiography, TTFM, computed tomography of the aorta and/or grafts
- Keywords
- CABG, ascending aortic aneurysm, aortic replacement, TTFM, MACCE
- Medical subject headings
- Coronary Artery Disease, Aneurysm, Ascending Aorta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG CT angiographyDiagnostic test
Preoperative: electrocardiography-gated computed tomographic angiography.
TTFMDiagnostic test
Intraoperative: TTFM after weaning from cardiopulmonary bypass and just before sternal closure.
computed tomography of the aorta and/or graftsDiagnostic test
computed tomography of the aorta and/or grafts within 2 weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| CABG (Coronary artery bypass grafting) | Experimental | 35 patients who underwent isolated coronary artery bypass grafting. Receives: Diagnostic Test: ECG CT angiography; Diagnostic Test: TTFM; Diagnostic Test: computed tomography of the aorta and/or grafts |
| CABG+AAR (Coronary artery bypass grafting concomitant with ascending aortic replacement) | Experimental | 35 patients who underwent CABG concomitant with ascending aortic replacement. Receives: Diagnostic Test: ECG CT angiography; Diagnostic Test: TTFM; Diagnostic Test: computed tomography of the aorta and/or grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
major adverse cerebral and cardiac events (MACCE).
The difference in the incidence of MACCE between groups (p-value)
Measured: 12 months
Secondary outcomes (3)
Respiratory failure (%)
The difference in the incidence of respiratory failure (p-value)
Measured: Perioperative
Acute kidney injury requiring renal replacement therapy (%)
The difference in the incidence of renal replacement therapy during follow-up (p-value)
Measured: Perioperative
Re-exploration rate (%)
The difference in the incidence of re-operation for bleeding during follow-up (p-value)
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start20 Jan 2013
- Primary completion20 Jun 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tomsk Cardiology Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris N. Kozlov, MD, PhD, Principal investigator, Cardiology Research Institute, Tomsk National Research Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071857
- Sponsor's protocol ID
- CASE
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Bypass Grafting With Concomitant Ascending Aortic Replacement: a Case-control Study
- ClinicalTrials.gov ID
- NCT07071857
- Acronym / sponsor ID
- CASE
- Conditions
- Coronary Artery Disease, Ascending Aortic Aneurysm
- Keywords
- CABG, ascending aortic aneurysm, aortic replacement, TTFM, MACCE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tomsk Cardiology Research InstituteUniversity, hospital or other
- Study start
- 20 Jan 2013 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 17 Jul 2025 (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.
This retrospective study investigates early outcomes after CABG as well as graft patency rate in patients with concomitant AAR. 35 patients undergoing CABG with concomitant AAR (CABG+AAR group) were case-control matched to 35 patients who received isolated CABG (CABG group) in regard to transit-time flow measurement (TTFM) findings, early and late outcomes.
Detailed description
- Relevance of the study. Coronary artery bypass grafting is an effective treatment for patients with coronary artery disease (CAD). Nowadays, this operation is the most common surgical procedure performed on the heart, with >600,000 operations per year worldwide. Approximately 15-20% of patients with CAD require concomitant cardiac surgery with relatively high incidence of postoperative morbidity and mortality. It is considered that concomitant CAD in patients undergoing thoracic aortic surgery is an independent risk factor for perioperative mortality. Taking into account the recently published data, CABG added to other cardiac surgeries is associated with increased short- and long-term mortality. There are no available data on the relationship between the outcomes of the concomitant CABG and the patency of coronary grafts. The aim of this study was to assess the early outcomes after CABG as well as graft patency rate in patients with concomitant AAR.
- Patients and methods. 35 patients who underwent CABG concomitant with ascending aortic replacement (CABG+AAR group) were compared with 35 patients who underwent isolated CABG (CABG group). Baseline characteristics which included preoperative characteristics, details on surgery (duration of cardiopulmonary bypass, cardioplegic arrest, antegrade cerebral perfusion), and early and late postoperative outcomes were compared between these groups.
Imaging All aortic measurements and postoperative graft patency were assessed by electrocardiography-gated computed tomographic angiography. Postoperative computed tomography of the aorta and/or grafts was performed within 2 weeks after surgery. 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. All measurements were taken always in the plane perpendicular to the manually corrected local aortic centre line. Ascending aortic diameter was measured at the level of the pulmonary artery bifurcation. The maximum aortic diameter (mm) was measured from the outer contours of the aortic wall.
The postoperative graft status was classified according to Fitzgibbon classification where Grade A is a patent graft, grade B is a stenosed graft (<50% of the grafted coronary artery) or a string sign and grade O is an occluded graft. All images were independently assessed by two experienced cardiologists.
Surgical technique CABG surgery was performed in the standard manner with a cardiopulmonary bypass and carioplegic arrest. Left internal mammary arterial (LIMA) grafts were used as in situ grafts to the LAD in all of the cases. All saphenous vein grafts (SVGs) were used in an aortocoronary bypass fashion. Proximal anastomoses were sewn to the aorta/graft with side-biting clamp on the beating heart.
The surgery was performed through a median sternotomy under mild-to-moderate hypothermia (28-30°C) and antegrade cerebral perfusion via the innominate artery with side graft. The distal aortic anastomosis was 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 (hemiarch repair). Near infrared spectroscopy (Invos 5100, Somanetics Corp., USA) was used for cerebral monitoring during the operation. When the target temperature was achieved, lower body circulatory arrest with antegrade cerebral perfusion was initiated. The distal aortic anastomosis was performed with a running 4/0 polypropylene suture with a Dacron graft. Proximal aortic anastomosis as well as coronary artery bypass grafting was performed during the rewarming period. The patient was weaned from cardiopulmonary bypass when the body temperature reached 36°C. The sequence of the surgical steps during the operation was the same for all patients.
Transit time flow measurement Graft flow tracing was recorded intraoperatively after weaning from cardiopulmonary bypass and just before sternal closure with a transit-time flowmeter (VQ1001, Medi-Stim AS, Oslo, Norway). The haemodynamic condition remained stable with a mean blood pressure between 70 and 90 mmHg during the flow measurement. The device displays a flow curve and calculates the mean graft flow (MGF) (ml/min), pulsatile index (PI) and diastolic filling percentage (DF%). The TTFM criteria for graft revision were MGF of <5 ml/min, PI of >5 or DF ratio of <50%.
Follow-up Follow-up was performed according to the institutional database supplemented by individual patient records. Data was obtained via medical records of clinical encounters or phone calls with patients and/or relatives. Postoperative computed tomographic scans and angiograms were performed upon discharge, at 12 months from the last procedure and annually thereafter.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CABG (Coronary artery bypass grafting) | Experimental | Diagnostic Test: ECG CT angiography, Diagnostic Test: TTFM, Diagnostic Test: computed tomography of the aorta and/or grafts35 patients who underwent isolated coronary artery bypass grafting. |
| CABG+AAR (Coronary artery bypass grafting concomitant with ascending aortic replacement) | Experimental | Diagnostic Test: ECG CT angiography, Diagnostic Test: TTFM, Diagnostic Test: computed tomography of the aorta and/or grafts35 patients who underwent CABG concomitant with ascending aortic replacement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80 years.
- Signed informed consent.
- Severe left main stem artery stenosis, or left main equivalent disease (70% or greater stenosis in diameter of the left anterior descending artery, proximal left circumflex artery and right coronary artery).
- Ascending aorta greater than 5 cm.
Key exclusion criteria (3 listed)
- Dissections or urgent/emergent cases.
- Redo aortic surgery.
- Total aortic arch surgery.
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 |
|---|---|---|
| ECG CT angiographyPreoperative: electrocardiography-gated computed tomographic angiography. | Diagnostic test | CABG (Coronary artery bypass grafting), CABG+AAR (Coronary artery bypass grafting concomitant with ascending aortic replacement) |
| TTFMIntraoperative: TTFM after weaning from cardiopulmonary bypass and just before sternal closure. | Diagnostic test | CABG (Coronary artery bypass grafting), CABG+AAR (Coronary artery bypass grafting concomitant with ascending aortic replacement) |
| computed tomography of the aorta and/or graftscomputed tomography of the aorta and/or grafts within 2 weeks after surgery. | Diagnostic test | CABG (Coronary artery bypass grafting), CABG+AAR (Coronary artery bypass grafting concomitant with ascending aortic replacement) |
Primary outcome
major adverse cerebral and cardiac events (MACCE).
Time frame: 12 months
The difference in the incidence of MACCE between groups (p-value)
3 secondary outcomes
Respiratory failure (%)
Time frame: Perioperative
Acute kidney injury requiring renal replacement therapy (%)
Time frame: Perioperative
Re-exploration rate (%)
Time frame: Perioperative
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 17 Jul 2025.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (text, tables, figures, and appendices), underlying the results of the trial, will be shared with researchers to achieve the aims in the approved proposal
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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, MD, PhD principal investigator
Cardiology Research Institute, Tomsk National Research Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing ECG CT angiography, TTFM and computed tomography of the aorta and/or grafts in people with Coronary Artery Disease and Ascending Aortic Aneurysm, run by Tomsk Cardiology Research Institute.
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 4 inclusion and 3 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 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
major adverse cerebral and cardiac events (MACCE). (time frame: 12 months). 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 17 Jul 2025.