ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12622000774729

Ethics application status

Approved

Date submitted

12/04/2022

Date registered

31/05/2022

Date last updated

28/07/2024

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]

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

Coronary artery bypass grafting

Condition category

Condition code

Cardiovascular

Coronary heart disease

Surgery

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Flow distribution ratio in the branches of arterial composite graft determined by intraoperative ultrasonography using Medistim MiraQ Cardiac device.

Timepoint [1]

Perioperatively

Secondary outcome [1]

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]

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?

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

Completed

Date of first participant enrolment

Anticipated

6/06/2022

Actual

6/06/2022

Date of last participant enrolment

Anticipated

30/10/2023

Actual

30/10/2023

Date of last data collection

Anticipated

30/10/2028

Actual

30/10/2023

Sample size

Target

100

Accrual to date

Final

Recruitment outside Australia

Country [1]

Czech Republic

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

General Universitiy Hospital in Prague

Address [1]

U Nemocnice 499/2
12808
Praha 2

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Ethics Committee of the General University Hospital in Prague

Ethics committee address [1]

U Nemocnice 499/2
12808
Praha 2

Ethics committee country [1]

Czech Republic

Date submitted for ethics approval [1]

06/12/2021

Approval date [1]

31/12/2021

Ethics approval number [1]

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

Dr Matus Niznansky

Address

Department of Cardiovascular Surgery
General University Hospital in Prague
U nemocnice 499/2
12808
Praha 2

Country

Czech Republic

Phone

+420776460902

Fax

matus.niznansky@vfn.cz

Contact person for public queries

Name

Matus Niznansky

Address

Department of Cardiovascular Surgery
General University Hospital in Prague
U nemocnice 499/2
12808
Praha 2

Country

Czech Republic

Phone

+420776460902

Fax

matus.niznansky@vfn.cz

Contact person for scientific queries

Name

Matus Niznansky

Address

Department of Cardiovascular Surgery
General University Hospital in Prague
U nemocnice 499/2
12808
Praha 2

Country

Czech Republic

Phone

+420776460902

Fax

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.	Type	Email
15767	Informed consent form	matus.niznansky@vfn.cz
15768	Ethical approval	matus.niznansky@vfn.cz
15769	Clinical study report	matus.niznansky@vfn.cz
15770	Analytic code	matus.niznansky@vfn.cz
15984	Study protocol	matus.niznansky@vfn.cz
15985	Statistical analysis plan	matus.niznansky@vfn.cz

Results publications and other study-related documents

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No additional documents have been identified.

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