Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000954527
Ethics application status
Not yet submitted
Date submitted
8/08/2015
Date registered
11/09/2015
Date last updated
11/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of patient-specific multi-scale computer modelling to aid decision making versus standard decision making by surgeon on coronary blood flows in patients undergoing coronary artery bypass graft surgery
Scientific title
Effect of patient-specific multi-scale computer modelling to aid decision making versus standard decision making by surgeon on coronary blood flows in patients undergoing coronary artery bypass graft surgery
Secondary ID [1] 287247 0
Nil
Universal Trial Number (UTN)
Trial acronym
COMCAB study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 295862 0
Coronary Artery Bypass Graft Surgery 295909 0
Condition category
Condition code
Cardiovascular 296112 296112 0 0
Coronary heart disease
Surgery 296339 296339 0 0
Surgical techniques

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Computer model will be created on the basis of each patients coronary angiogram and cardiac CT scan. Patients will have intraoperative measurements done by ultrasound of the flows down their grafts and coronary arteries as well as an additional post-operative cardiac CT scan. The intraoperative measurements will be take less than 5 minutes and will not increase cardiopulmonary bypass time. The surgeon performing the operation will show their own discretion as to what grafting procedure they will perform. Other surgeons will be surveyed afterwards and given the information of the computer model and will be free to interpret the model at their discretion to decide what grafting strategy they would have used. This will include which vessels they would have chosen to graft, whether or not they would use sequential grafts and which conduits they would use.
Intervention code [1] 292539 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295787 0
Coronary blood flows calculated from a validated computer model that uses virtual flows comparing the difference between the optimal strategy determined by the computer and an individual surgeon's conventional strategy without the aid of the computer model. Then the optimal computer strategy wil be compared with the surgeons' strategy having been given information from the computer model.
Timepoint [1] 295787 0
After surgeons have been surveyed regarding their individual strategies, their grafting strategies will be given as inputs to the computer model and the outputs will be compared with the optimal grafting strategy.
Secondary outcome [1] 316672 0
Coronary blood flows calculated from a validated computer model that uses virtual flows comparing the difference between the optimal strategy determined by the computer and the pooled surgeons' strategy without the aid of the computer model. Then the optimal computer strategy wil be compared with the pooled surgeons' strategy having been given information from the computer model.
Timepoint [1] 316672 0
This will be measured after the surgeons have been surveyed to rank their colleagues' individual grafting strategies for a particular patient

Eligibility
Key inclusion criteria
Patients
*undergoing a planned isolated coronary artery bypass grafting operation
*competence to provide informed consent
*normal left ventricular ejection fraction

Surgeons
*an expert in coronary surgery having been in practice for at least 10 years and/or performed more than 1000 coronary artery cases
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients
*emergency or salvage coronary artery bypass operations
*significant renal impairment

Surgeons
*not willing to provide informed consent to participate in the study

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
The number of cardiac surgeons participating in the survey was determined at 5 minimum, given the large number of criteria, alternatives and attributes that their decision-making process will entail. In order to power the number of pre-operative patients' data that are required for analysis by the computer and the surgeons, the flow estimated in a distal coronary artery can be estimated at 18 ml/min, based on previous studies. A change in blood flow post grafting by 33% was significant in these studies, and with an estimated standard deviation of 6 ml/min with alpha level 0.05 and power 0.8, requires 8 patients' data. To account for dropout, 2 adiitional patients will be included, giving a total of 10 patients. For the primary outcome measure, difference in coronary blood flows will be compared for an individual patient between the optimal computer strategy and individual surgeon decision. Using ANOVA with Greenhouse-Geissser correction for multi-sample sphericity and Bonferonni adjustment for post-hoc analysis. The values will be compared between perfusion territories using ANOVA. The intraobserver and interobserver assessment of coronary blood flows from the computer model will be assessed by means of the coefficient of variation. The level of statistical significance will be set at a p-value <0.05 and the statistical tests will be two-tailed.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/11/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 7085 0
New Zealand
State/province [1] 7085 0
Auckland

Funding & Sponsors
Funding source category [1] 291812 0
Charities/Societies/Foundations
Name [1] 291812 0
Royal Australasian College of Surgeons Grant
Country [1] 291812 0
Australia
Primary sponsor type
Hospital
Name
Auckland City Hospital
Address
Auckland City Hospital
Main Building
Park Road
Grafton 1023
Country
New Zealand
Secondary sponsor category [1] 290474 0
University
Name [1] 290474 0
The University of Auckland
Address [1] 290474 0
The Univeristy of Auckland
20 Symonds Street
Auckland 1010
Country [1] 290474 0
New Zealand

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 293332 0
ADHB (A+) Research Office
Ethics committee address [1] 293332 0
Ethics committee country [1] 293332 0
New Zealand
Date submitted for ethics approval [1] 293332 0
21/08/2015
Approval date [1] 293332 0
Ethics approval number [1] 293332 0

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

Contacts
Principal investigator
Name 59414 0
Mr Krish Chaudhuri
Address 59414 0
Auckland City Hospital
Main Building
Level 4, Room 43.096
Park Road
Grafton 1023
Auckland
Country 59414 0
New Zealand
Phone 59414 0
+64 9 307 4949
Fax 59414 0
Email 59414 0
[email protected]
Contact person for public queries
Name 59415 0
Krish Chaudhuri
Address 59415 0
Auckland City Hospital
Main Building
Level 4, Room 43.096
Park Road
Grafton 1023
Auckland
Country 59415 0
New Zealand
Phone 59415 0
+64 9 307 4949
Fax 59415 0
Email 59415 0
[email protected]
Contact person for scientific queries
Name 59416 0
Krish Chaudhuri
Address 59416 0
Auckland City Hospital
Main Building
Level 4, Room 43.096
Park Road
Grafton 1023
Auckland
Country 59416 0
New Zealand
Phone 59416 0
+64 9 307 4949
Fax 59416 0
Email 59416 0
[email protected]

No information has been provided regarding IPD availability


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.