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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00475488




Registration number
NCT00475488
Ethics application status
Date submitted
17/05/2007
Date registered
21/05/2007

Titles & IDs
Public title
Radial Artery Patency and Clinical Outcomes Trial
Scientific title
Randomised Trial of Graft Patency and Clinical Outcomes, Comparing Radial Artery With Either the Right Internal Thoracic Artery or Saphenous Vein
Secondary ID [1] 0 0
V1111-1166-3083
Secondary ID [2] 0 0
H2006/02690
Universal Trial Number (UTN)
Trial acronym
RAPCO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease 0 0
Atherosclerosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Coronary artery bypass grafting

Other: Group 1 - Radial Artery versus Right Internal Thoracic Artery when used as a coronary conduit in patients undergoing multi-vessel coronary artery bypass grafting.

Other: Group 2 - Radial Artery versus Saphenous Vein when used as a coronary conduit in patients undergoing multi-vessel coronary artery bypass grafting.


Treatment: Surgery: Coronary artery bypass grafting
Surgery performed due to coronary artery disease.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Graft patency on all surviving trial patients.
Timepoint [1] 0 0
Between 1-10 years from CABG surgery.
Secondary outcome [1] 0 0
All cause mortality ·
Timepoint [1] 0 0
10 years from CABG surgery
Secondary outcome [2] 0 0
Event free Survival
Timepoint [2] 0 0
10 years from CABG surgery

Eligibility
Key inclusion criteria
* The patient is scheduled for primary coronary artery bypass surgery alone ie. no reoperations, no associated procedures
* The patient requires more than 1 graft, that is, there are at least 2 coronary artery stenoses of > 70%.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Renal disease with a creatinine >0.30 mmol/L.
* Chronic heart failure (NYHA Class III or IV or ejection fraction <35% on angiography or radionuclide ventriculography).
* Associated major illnesses e.g., malignancy.
* Body mass index (BMI) > 35; weight (kg)/height(m2).
* Acute presentation, that is, those patients who have an acute myocardial infarct within one week prior to surgery or who present with cardiogenic shock.
* Technical exclusions e.g. sequential grafting.
* Failure to obtain informed consent.
* Off pump.

GROUP 1 Specific exclusions

* Failure to use radial artery due to abnormal Allen Test (>10 sec)
* Failure to be able to use the FRIMA eg. Chest trauma
* FEV1 < 50% of expected value
* Diabetic patients (IDDM or NIDDM) =60 years
* Patients =70 years

GROUP 2

* Specific exclusions
* Failure to use radial artery due to abnormal Allen Test (>10 sec)
* Failure to be able to use the saphenous vein eg. Varices, past trauma
* Diabetic patients <60 years of age
* Other patients <70 years of age

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
605
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
David L Hare, MB BS DPM FRACP FESC FACC
Address 0 0
Austin Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00475488