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CompletedNCT07071857Updated Jul 17, 2025

Coronary Artery Bypass Grafting With Ascending Aortic Replacement

An interventional study of ECG CT angiography and TTFM in Coronary Artery Disease and Ascending Aortic Aneurysm, sponsored by Tomsk Cardiology Research Institute. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-07-17.

Sponsored by Tomsk Cardiology Research Institute · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 12 years 5 months after the study started (first participant enrolled Jan 2013, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 (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.

02

Conditions studied

  • Coronary Artery Disease
  • Ascending Aortic Aneurysm

Keywords

  • CABG
  • ascending aortic aneurysm
  • aortic replacement
  • TTFM
  • MACCE
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 70 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Tomsk Cardiology Research Institute is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age 18-80 years.
  2. Signed informed consent.
  3. 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).
  4. Ascending aorta greater than 5 cm.

Exclusion criteria

Exclusion Criteria:

  1. Dissections or urgent/emergent cases.
  2. Redo aortic surgery.
  3. Total aortic arch surgery.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    CABG (Coronary artery bypass grafting)

    35 patients who underwent isolated coronary artery bypass grafting.

    Diagnostic Test: ECG CT angiography · Diagnostic Test: TTFM · Diagnostic Test: computed tomography of the aorta and/or grafts

  • Experimental
    CABG+AAR (Coronary artery bypass grafting concomitant with ascending aortic replacement)

    35 patients who underwent CABG concomitant with ascending aortic replacement.

    Diagnostic Test: ECG CT angiography · Diagnostic Test: TTFM · Diagnostic Test: computed tomography of the aorta and/or grafts

Interventions

  • Diagnostic testECG CT angiography

    Preoperative: electrocardiography-gated computed tomographic angiography.

  • Diagnostic testTTFM

    Intraoperative: TTFM after weaning from cardiopulmonary bypass and just before sternal closure.

  • Diagnostic testcomputed tomography of the aorta and/or grafts

    computed tomography of the aorta and/or grafts within 2 weeks after surgery.

06

What researchers measure

Primary outcomes

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

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

    Time frame: 12 months

Secondary outcomes

  1. Respiratory failure (%)

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

    Time frame: Perioperative

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

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

    Time frame: Perioperative

  3. Re-exploration rate (%)

    The difference in the incidence of re-operation for bleeding during follow-up (p-value)

    Time frame: Perioperative

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: 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

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07071857
Lead sponsor
Tomsk Cardiology Research Institute
Responsible party
Sponsor
First posted
Jul 17, 2025
Start date
Jan 20, 2013
Primary completion
Jun 20, 2021
Completion
Dec 20, 2021
Last update
Jul 17, 2025

Study contacts

Boris N. Kozlov, MD, PhD
principal investigator · Cardiology Research Institute, Tomsk National Research Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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