NCT07071857

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable coronary-artery-disease

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2013

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

July 4, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

8.4 years

First QC Date

July 4, 2025

Last Update Submit

July 15, 2025

Conditions

Coronary Artery DiseaseAscending Aortic Aneurysm

Keywords

CABGascending aortic aneurysmaortic replacementTTFMMACCE

Outcome Measures

Primary Outcomes (1)

  • major adverse cerebral and cardiac events (MACCE).

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

    12 months

Secondary Outcomes (3)

  • Respiratory failure (%)

    Perioperative

  • Acute kidney injury requiring renal replacement therapy (%)

    Perioperative

  • Re-exploration rate (%)

    Perioperative

Study Arms (2)

CABG (Coronary artery bypass grafting)

EXPERIMENTAL

35 patients who underwent isolated coronary artery bypass grafting.

Diagnostic Test: ECG CT angiographyDiagnostic Test: TTFMDiagnostic 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.

Diagnostic Test: ECG CT angiographyDiagnostic Test: TTFMDiagnostic Test: computed tomography of the aorta and/or grafts

Interventions

ECG CT angiographyDIAGNOSTIC_TEST

Preoperative: electrocardiography-gated computed tomographic angiography.

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

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

CABG (Coronary artery bypass grafting)CABG+AAR (Coronary artery bypass grafting concomitant with ascending aortic replacement)
computed tomography of the aorta and/or graftsDIAGNOSTIC_TEST

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

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Dissections or urgent/emergent cases.
  • Redo aortic surgery.
  • Total aortic arch surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery DiseaseAneurysm, Ascending Aorta

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAortic Aneurysm, ThoracicAortic AneurysmAneurysmAortic Diseases

Study Officials

  • Boris N. Kozlov, MD, PhD

    Cardiology Research Institute, Tomsk National Research Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 17, 2025

Study Start

January 20, 2013

Primary Completion

June 20, 2021

Study Completion

December 20, 2021

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Proposals may be submitted up to 36 months following publication of the results of the trial. After 36 months, the data will be available in the Center's data ware house but without investigator support other than deposited metadata
Access Criteria
Information regarding submitting proposals and accessing data may be requested from the principal investigator by e-mail.