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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT00475488
Ethics application status
Date submitted
17/05/2007
Date registered
21/05/2007
Date last updated
11/05/2016

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
Other cardiovascular diseases
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. - Graft failure defined as either total occlusion, stenosis >80% or string sign.
Timepoint [1] 0 0
Between 1-10 years from CABG surgery.
Secondary outcome [1] 0 0
All cause mortality · - Clinical follow-up and Australian National Death Registry
Timepoint [1] 0 0
10 years from CABG surgery
Secondary outcome [2] 0 0
Event free Survival - Events defined as all-cause mortality, myocardial infarction, revascularisation (percutaneous or surgical).
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
Gender
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 status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Other
Name
Austin Health
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Coronary Artery Bypass Graft (CABG)Surgery is commonly used to treat patients with coronary
artery disease (atherosclerosis) for the relief of angina (chest pain) and improve heart
muscle function.

Healthy veins or arteries, referred to as 'conduits' from elsewhere in the patient's body,
are grafted (attached) from the aorta to the coronary arteries, bypassing (via new routes)
coronary artery narrowings caused by atherosclerosis (hardening of the arteries) and thereby
improving the blood supply to the myocardium (heart muscle).

Over the years, a range of different veins and arteries from around the body have been used
to bypass diseased coronary arteries. Typically, internal thoracic arteries from behind the
breastbone and the saphenous veins from the legs are used for bypass. More recently, radial
arteries from the forearm have also been used to bypass coronary arteries that are diseased
(atherosclerotic). There is strong evidence to indicate that the left internal thoracic
artery stays open the longest (i.e. has the highest patency) and achieves the best health
outcomes. As a result, most cardiac surgeons use the left internal thoracic artery as their
first choice of conduit (vessel used to bypass the blocked artery). However, many patients
require multiple grafts and there is little evidence as to which grafts are the best conduits
to use.

It has been suggested that the radial arteries might function better than saphenous veins as
conduits. The Radial Artery Patency and Clinical Outcomes Trial(RAPCO) aims to compare
patency of the radial arteries with the right internal thoracic artery and also with the
saphenous vein.
Trial website
https://clinicaltrials.gov/show/NCT00475488
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brian F Buxton, MB BS FRACS FRCS FACS FRCS(C)
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

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00475488