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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.

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

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
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
  1. 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.
  2. 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.

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 groups in NCT07071857
Study groupRoleWhat they receive
CABG (Coronary artery bypass grafting)Experimental35 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)Experimental35 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.

  1. major adverse cerebral and cardiac events (MACCE).

    The difference in the incidence of MACCE between groups (p-value)

    Measured: 12 months

Secondary outcomes (3)
  1. Respiratory failure (%)

    The difference in the incidence of respiratory failure (p-value)

    Measured: Perioperative

  2. Acute kidney injury requiring renal replacement therapy (%)

    The difference in the incidence of renal replacement therapy during follow-up (p-value)

    Measured: Perioperative

  3. 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.

  1. First posted17 Jul 2025
  2. Study start20 Jan 2013
  3. Primary completion20 Jun 2021
  4. Study completion20 Dec 2021

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (actual)
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

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.

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