Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000137190
Ethics application status
Approved
Date submitted
23/01/2019
Date registered
30/01/2019
Date last updated
15/09/2020
Date data sharing statement initially provided
30/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Three-stages assessment of coronary artery bypass grafts patency by intraoperative
transit time flow measurement
Scientific title
Evaluation of coronary artery bypass grafts by intraoperative
transit time flow measurement in three stages; on the resting heart, on beating heart, after heparin inactivation.
Secondary ID [1] 297163 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery bypass grafting patency 311195 0
Condition category
Condition code
Surgery 309815 309815 0 0
Other surgery
Cardiovascular 309925 309925 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized study comparing two groups of patients undergoing coronary artery bypass grafting (CABG) at our institute, where patient first group underwent transit time flow measurements (TTFM) of all bypass grafts using the VeriQ system (MediStim Inc., Oslo, Norway). The TTFM values of all grafts were recorded intra-operatively in three stages: 1. Immediately after performing of the all distal anastomoses (with proximal snare on target corfonary artery and without it), 2. after the patient was weaned from cardiopulmonary bypass and the hemodynamic condition was assessed as being stable, 3. after heparin inactivation, before chest closure.
Materials: Two hundred patients listed for CABG
Procedures: All CABGs were performed through a median sternotomy during cardiopulmonary bypass. Full heparinization was given.
Who: heart surgeon with 10 years experience
Mode of delivery: face to face
Number of times: twice / week
Intervention code [1] 313423 0
Treatment: Surgery
Comparator / control treatment
Standart CABG without routinely underwent TTFM
Control group
Active

Outcomes
Primary outcome [1] 318774 0
The effect three-stages TTFM on a number grafts revised. All measurement will performe using a TTFM (VeriQ System, Medistim, Oslo, Norway). Based on graft diameter, either 3 or 4 mm, a flow probe was used for flow measurement. Flow parameters recorded in this study included mean graft flow, pulsatility index and diastolic filling. The flow parameters were recorded after waveform of graft flow and values became stable. First measure will be done when all distal anasamoses will be performed, during heart in arrest (free bypass grafts will be connected to arterial canula on cardio-pulmonary bypass during thise measure). Also first measure will be done with proximal snare on target corfonary artery and without it, Second measure will be done after all proximal anasamoses will be completed and after weaning from cardio-pulmonary bypass, Third measure will be done after protamine, and immediately before chest closure.
Abnormal flowmetery was considered to be present with a pulsatility index of more than 5 and the shape of the waveform with a spikes. This is indications for grafts revised.
Timepoint [1] 318774 0
Intraoperatively,
Primary outcome [2] 318775 0
The effect three-stages TTFM on major adverse cardiac events (MACE) (which are death from any cause, myocardial infarction [MI], or unplanned revascularization for ischemia). This outcome is assessed by data-linkage to medical records.
Timepoint [2] 318775 0
all 30-day
Secondary outcome [1] 366001 0
The effect three-stages TTFM on major adverse cardiac events (MACE) (which are death from any cause, myocardial infarction [MI], or unplanned revascularization for ischemia). This outcome is assessed by data-linkage to medical records.
Timepoint [1] 366001 0
at 1 and 3 year after operation
Secondary outcome [2] 366002 0
The effect three-stages TTFM on grafts patency by Computed Tomographic Angiography
Timepoint [2] 366002 0
at 1 and 3 years after operation

Eligibility
Key inclusion criteria
coronary artery disease
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Concomitant surgery (valve surgery, aorta surgery)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2019
Actual
1/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
300
Accrual to date
87
Final
Recruitment outside Australia
Country [1] 21224 0
Russian Federation
State/province [1] 21224 0

Funding & Sponsors
Funding source category [1] 301715 0
Government body
Name [1] 301715 0
Department of Health
Country [1] 301715 0
Russian Federation
Primary sponsor type
Government body
Name
Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”
Address
Russia, Tomsk city, Cooperative street 5,postcode 634009
Country
Russian Federation
Secondary sponsor category [1] 301488 0
None
Name [1] 301488 0
None
Address [1] 301488 0
None
Country [1] 301488 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302436 0
Ethics committee of Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”
Ethics committee address [1] 302436 0
Russia, Tomsk city, Cooperative street 5,postcode 634009
Ethics committee country [1] 302436 0
Russian Federation
Date submitted for ethics approval [1] 302436 0
Approval date [1] 302436 0
01/03/2017
Ethics approval number [1] 302436 0

Summary
Brief summary
Intraoperative graft failure is a potentially avoidable major
cause of cardiac morbidity and mortality and occurs in up to
3% of grafts (8% of patients) after coronary artery bypass
grafting. At present, transit-time flow measurement (TTFM) is the most
common intraoperative method for assessing graft function. Our randomized study using the VeriQ system allows to verify the adequacy of the grafts patency at all stages of the operation. In this way the TTFM values of all grafts were recorded intra-operatively in three stages: 1. Immediately after performing of the all distal anastomoses (with proximal snare on target corfonary artery and without it), 2. after the patient was weaned from cardiopulmonary bypass and the hemodynamic condition was assessed as being stable, 3. after heparin inactivation, before chest closure. This allows to control the grafts functionality after performing of each anastomosis and correct the surgical error immediately, without restoring repeat cardiac arrest.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90234 0
Dr Zatolokin Vasily Viktorovich
Address 90234 0
Russia, Tomsk, Kievskaya street 111A.
Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”.
Director academician Popov Sergey Valentinovich
Country 90234 0
Russian Federation
Phone 90234 0
+79138490545
Fax 90234 0
Email 90234 0
[email protected]
Contact person for public queries
Name 90235 0
Dr Zatolokin Vasily Viktorovich
Address 90235 0
Russia, Tomsk, Kievskaya street 111A.
Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”.
Director academician Popov Sergey Valentinovich
Country 90235 0
Russian Federation
Phone 90235 0
+79138490545
Fax 90235 0
Email 90235 0
[email protected]
Contact person for scientific queries
Name 90236 0
Dr Zatolokin Vasily Viktorovich
Address 90236 0
Russia, Tomsk, Kievskaya street 111A.
Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”.
Director academician Popov Sergey Valentinovich
Country 90236 0
Russian Federation
Phone 90236 0
+79138490545
Fax 90236 0
Email 90236 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial
When will data be available (start and end dates)?
Immediately following publication, no end date.
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.