Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000774729
Ethics application status
Approved
Date submitted
12/04/2022
Date registered
31/05/2022
Date last updated
4/08/2023
Date data sharing statement initially provided
31/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Flow distribution in arterial composite grafts in patients with coronary heart disease undergoing coronary artery bypass grafting
Scientific title
Transit time flow measurement analysis of flow distribution in arterial composite grafts in patients undergoing coronary artery bypass grafting
Secondary ID [1] 306884 0
GIP-22-SL (General University Hospital in Prague fund numer)
Universal Trial Number (UTN)
Trial acronym
FLODAC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coronary heart disease 325982 0
Coronary artery bypass grafting 326252 0
Condition category
Condition code
Cardiovascular 323297 323297 0 0
Coronary heart disease
Surgery 323557 323557 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study is based on the analysis of transit time flow measurement of arterial composite graft branches during coronary artery bypass grafting with regards to the severity and ratio of stenoses of native target coronary arteries. The measurement will be performed and recorded immediately after all anastomoses are completed, Medistim MiraQ Cardiac ultrasound device will be used. Even or competitive flow distribution will be evaluated. There will be a second phase of the study - long term follow up of enrolled patients focused on the occurence of major adverse cardiac events. Participants will receive a brief phone call during which they will be asked to self-report major adverse cardiac events, follow up data will be collected at 6, 12, 24, 36, 48, and 60 months post-surgery. In case of death, this will be reported by patient's general practicioner, who will agree with this before the enrollement of patient into the study.
Intervention code [1] 323341 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331028 0
Flow distribution ratio in the branches of arterial composite graft determined by intraoperative ultrasonography using Medistim MiraQ Cardiac device.
Timepoint [1] 331028 0
Perioperatively
Secondary outcome [1] 408541 0
Major adverse cardiac events after coronary artery bypass grafting assessed by participant self-report. Monitored events include myocardial infarction, stroke, myocardial revascularization procedures and cardiovascular death. In case of death, this will be reported by patient's general practicioner, who will agree with this before the enrollement of patient into the study.
Timepoint [1] 408541 0
6, 12, 24, 36, 48, 60 months after operation

Eligibility
Key inclusion criteria
Patients with coronary heart disease indicated to coronary artery bypass grafting.
Surgeon indicates the use of arterial composite graft to revascularize left anterior descending artery and obtuse marginal artery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The use of sequential anastomoses.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/06/2022
Actual
6/06/2022
Date of last participant enrolment
Anticipated
30/10/2023
Actual
Date of last data collection
Anticipated
30/10/2028
Actual
Sample size
Target
100
Accrual to date
55
Final
Recruitment outside Australia
Country [1] 24715 0
Czech Republic
State/province [1] 24715 0

Funding & Sponsors
Funding source category [1] 311195 0
Hospital
Name [1] 311195 0
General Universitiy Hospital in Prague
Country [1] 311195 0
Czech Republic
Primary sponsor type
Hospital
Name
General Universitiy Hospital in Prague
Address
U Nemocnice 499/2
12808
Praha 2
Country
Czech Republic
Secondary sponsor category [1] 312567 0
None
Name [1] 312567 0
Address [1] 312567 0
Country [1] 312567 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310727 0
Ethics Committee of the General University Hospital in Prague
Ethics committee address [1] 310727 0
U Nemocnice 499/2
12808
Praha 2
Ethics committee country [1] 310727 0
Czech Republic
Date submitted for ethics approval [1] 310727 0
06/12/2021
Approval date [1] 310727 0
31/12/2021
Ethics approval number [1] 310727 0
117/21 Grant GIP

Summary
Brief summary
Prospective observational study that is based on the analysis of the flow distribution in arterial composite graft that is used for surgical myocardial revascularization (coronary artery bypass grafting). Composite graft is a bypass configuration in which a free arterial graft is anastomosed to the side of a primary in situ arterial graft that provides the blood supply to the whole conduit. Each of the branches of such composite graft can be anastomosed to a different target coronary artery. According to current knowledge and published studies, it is unclear, whether the flow distribution within the branches of composite graft is even or competitive and whether this is affected by the severity and ratio of stenoses of the target coronary arteries. Our study should provide an answer to two questions:
The first is, whether the composite graft can be used in all patients thank to the even distribution of the flow within the branches, or whether there is a competitive flow due to different severity of stenoses of target coronary arteries and if so what degree of such difference or ratio of stenoses is responsible for flow competition. In all patients enrolled into the study we will measure the flow in both branches of the composite graft once the revascularization is complete and then will provide a statistical analysis to find out whether there is any correlation between the ratio of stenoses of the target vessels and the ratio of the flow in the branches of composite graft. The flow will be measured using the transit time flow measurement (TTFM) technology
The second question is whether the findings of the flow distribution have any long-term impact on the occurrence of the major adverse cardiac events (MACE) after coronary artery bypass grafting. All patients will be questioned regarding the occurrence of MACEs 6, 12, 24, 36, 48 and 60 months after operation. The obtained data will be then statistically analyzed.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118658 0
Dr Matus Niznansky
Address 118658 0
Department of Cardiovascular Surgery
General University Hospital in Prague
U nemocnice 499/2
12808
Praha 2
Country 118658 0
Czech Republic
Phone 118658 0
+420776460902
Fax 118658 0
Email 118658 0
matus.niznansky@vfn.cz
Contact person for public queries
Name 118659 0
Dr Matus Niznansky
Address 118659 0
Department of Cardiovascular Surgery
General University Hospital in Prague
U nemocnice 499/2
12808
Praha 2
Country 118659 0
Czech Republic
Phone 118659 0
+420776460902
Fax 118659 0
Email 118659 0
matus.niznansky@vfn.cz
Contact person for scientific queries
Name 118660 0
Dr Matus Niznansky
Address 118660 0
Department of Cardiovascular Surgery
General University Hospital in Prague
U nemocnice 499/2
12808
Praha 2
Country 118660 0
Czech Republic
Phone 118660 0
+420776460902
Fax 118660 0
Email 118660 0
matus.niznansky@vfn.cz

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, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
researchers who provide a methodologically sound proposal, at the discretion of Primary Sponsor
Available for what types of analyses?
to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator (matus. niznansky@vfn.cz)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15767Informed consent form  matus.niznansky@vfn.cz
15768Ethical approval  matus.niznansky@vfn.cz
15769Clinical study report  matus.niznansky@vfn.cz
15770Analytic code  matus.niznansky@vfn.cz
15984Study protocol  matus.niznansky@vfn.cz
15985Statistical analysis plan  matus.niznansky@vfn.cz



Results publications and other study-related documents

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