Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000552785
Ethics application status
Approved
Date submitted
24/09/2020
Date registered
8/04/2022
Date last updated
8/04/2022
Date data sharing statement initially provided
8/04/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multiple Arterial Revascularization versus Single in a patients with coronary artery disease
Scientific title
Evaluation of using multiple or single arterial coronary bypass grafts on major adverse cardiac events in patients with coronary artery disease
Secondary ID [1] 302391 0
none
Universal Trial Number (UTN)
none
Trial acronym
MARS
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Coronary artery bypass grafting patency 319178 0
Coronary heart disease 325795 0
Condition category
Condition code
Surgery 317148 317148 0 0
Surgical techniques
Cardiovascular 323132 323132 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. Patient first group underwent multiarterial coronary bypass surgery (left and right mammary arteries, radial artery).
Materials: Two hundred patients listed for CABG
Procedures: All CABGs were performed through a median sternotomy during cardiopulmonary bypass. Full heparinization was given. It anticipated to take an additional 20 minutes for multiarterial coronary bypass surgery
Who: heart surgeon with 10 years experience
Mode of delivery: face to face
Number of times: twice / week to the surgeon performing the CABG procedure
All participants will be followed for up to 12 years after the initial surgery.
Intervention code [1] 318671 0
Treatment: Surgery
Comparator / control treatment
Conventional coronary artery bypass grafting: left internal mammary artery on left arterial descended, great saphenous vein on other coronary arteries. Anticipated duration of the 'conventional' coronary artery bypass grafting procedure is up to 180 minutes
Control group
Active

Outcomes
Primary outcome [1] 325220 0
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] 325220 0
Death from any cause, myocardial infarction [MI], or unplanned revascularization for ischemia are assessed for 30 days post-surgery.
Primary outcome [2] 325221 0
Coronary flow reserve on Single photon emission computed tomography (SPECT)
Timepoint [2] 325221 0
Assessed once at 30 days post-surgery
Secondary outcome [1] 387244 0
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] 387244 0
at 1 and 5 year after operation

Eligibility
Key inclusion criteria
coronary artery disease
Minimum age
40 Years
Maximum age
70 Years
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
Actual
24/09/2020
Date of last participant enrolment
Anticipated
27/03/2026
Actual
Date of last data collection
Anticipated
30/11/2038
Actual
Sample size
Target
300
Accrual to date
68
Final
Recruitment outside Australia
Country [1] 23013 0
Russian Federation
State/province [1] 23013 0
Tomsk

Funding & Sponsors
Funding source category [1] 306815 0
Government body
Name [1] 306815 0
Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”
Country [1] 306815 0
Russian Federation
Primary sponsor type
Government body
Name
Ministry of Science and Higher Education
Address
Russia , Moscow, Bryusov per., 21, 125009
Country
Russian Federation
Secondary sponsor category [1] 307375 0
None
Name [1] 307375 0
Address [1] 307375 0
Country [1] 307375 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306979 0
Ethics committee of Federal State Budgetary Scientific Institution “Tomsk National Research Medical Center of the Russian Academy of Sciences”
Ethics committee address [1] 306979 0
Ethics committee country [1] 306979 0
Russian Federation
Date submitted for ethics approval [1] 306979 0
Approval date [1] 306979 0
23/09/2020
Ethics approval number [1] 306979 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105634 0
Dr Zatolokin Vasily Viktorovich
Address 105634 0
Tomsk National Research Medical Center, Cardiovascular Surgery Department.
Russia, Tomsk, Kievskaya street 111A.
Postcode: 634012
Country 105634 0
Russian Federation
Phone 105634 0
+79138490545
Fax 105634 0
Email 105634 0
[email protected]
Contact person for public queries
Name 105635 0
Zatolokin Vasily Viktorovich
Address 105635 0
Tomsk National Research Medical Center, Cardiovascular Surgery Department.
Russia, Tomsk, Kievskaya street 111A.
Postcode: 634012
Country 105635 0
Russian Federation
Phone 105635 0
+79138490545
Fax 105635 0
Email 105635 0
[email protected]
Contact person for scientific queries
Name 105636 0
Zatolokin Vasily Viktorovich
Address 105636 0
Tomsk National Research Medical Center, Cardiovascular Surgery Department.
Russia, Tomsk, Kievskaya street 111A.
Postcode: 634012
Country 105636 0
Russian Federation
Phone 105636 0
+79138490545
Fax 105636 0
Email 105636 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.