Coronary Artery DiseaseRAPCONCT00475488
Radial Artery Patency and Clinical Outcomes Trial
A study testing Coronary artery bypass grafting in people with Coronary Artery Disease and Atherosclerosis, run by Austin Health at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Atherosclerosis
- What is being tested?
- Coronary artery bypass grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 605 participants
- Where
- 1 siteAustralia
- Study dates
- Jun 1996to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Trial of Graft Patency and Clinical Outcomes, Comparing Radial Artery With Either the Right Internal Thoracic Artery or Saphenous Vein
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).
Read more
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.
Read the detailed description
The Department of Cardiac Surgery at Austin Health is conducting a prospective randomised trial, stratified into two separate sub-studies. The first compares the radial artery with the right internal thoracic artery(as a free aorto-coronary graft) and the second comparies the radial artery with a saphenous vein graft. Each patient was to be followed for 10 years after their CABG surgery in order to assess both the pattern of graft survival over 10 years and also to record major clinical events.
The study was first given approval by the Austin Health Human Research Ethics Committee on August 18th,1995. Enrolment commenced in June 1996. Recruitment ceased in March 2005. Patients were randomly assigned to the control or experimental group, patients in both groups received the left internal thoracic artery to the left anterior decending(LAD) and the study graft as the second graft.
The gold standard measure for the comparison of conduits is through the use of post-operative angiograms. These angiograms assess how patent (open) the grafts are, and also offer quality assurance of the CABG surgery performed. To spread the graft patency end-points over the 10 years after CABG, patients undergo a second randomisation as to the time at which their graft patency is to be assessed. The timing of the graft study coronary angiogram is weighted towards the end of the 10 year period with the aim of having 10% at 1 year, 20% at 2 years, 20% at 5 years, 30% at 7.5 years and 30% at 10 years after CABG surgery. Clinical data is systematically collected to determine those patients who experience heart attack, repeat surgery, balloon angioplasty or death over subsequent years.
To enrich the number of mid-study graft patency end-points a protocol amendment(July 19th, 2002) was approved allowing patients to be offered a selective coronary angiogram at the 5 year anniversary of their surgery.
A further protocol amendment(November 16th, 2006) allowed coronary and graft CT angiography to be used optionally to replace selective angiography and also to offer all patients imaging at 10 years, in addition to the original pre-specified, randomised time of imaging.
As per the ethics approval and prior protocol amendments, lifelong followup is conducted on patients enrolled in the trial. As such, a RAPCO-Extension trial will be conducted, evaluating clinical outcomes at 15-years follow-up.
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Being tested
- Coronary artery bypass grafting
- Keywords
- radial artery, right internal thoracic artery, saphenous vein, grafts, coronary bypass surgery
- Medical subject headings
- Coronary Artery Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass graftingProcedure or surgery
Surgery performed due to coronary artery disease.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Radial Artery versus Right Internal Thoracic Artery when used as a coronary conduit in patients undergoing multi-vessel coronary artery bypass grafting. Receives: Procedure: Coronary artery bypass grafting |
| Group 2 | Other | Radial Artery versus Saphenous Vein when used as a coronary conduit in patients undergoing multi-vessel coronary artery bypass grafting. Receives: Procedure: Coronary artery bypass grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft patency on all surviving trial patients.
Graft failure defined as either total occlusion, stenosis >80% or string sign.
Measured: Between 1-10 years from CABG surgery.
Secondary outcomes (2)
All cause mortality ·
Clinical follow-up and Australian National Death Registry
Measured: 10 years from CABG surgery
Event free Survival
Events defined as all-cause mortality, myocardial infarction, revascularisation (percutaneous or surgical).
Measured: 10 years from CABG surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startJun 1996
- Primary completionApr 2015
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 605 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Austin Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, David L Hare, Austin Health
- Investigators
- David L Hare, MB BS DPM FRACP FESC FACC, Study director, Austin Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475488
- Sponsor's protocol ID
- H2006/02690
- Other IDs
- V1111-1166-3083
- Acronym
- RAPCO
- Status last verified
- May 2022
- First submitted
- 17 May 2007
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Buxton BF, Hayward PA, Raman J, Moten SC, Rosalion A, Gordon I, Seevanayagam S, Matalanis G, Benedetto U, Gaudino M, Hare DL; RAPCO Investigators*. Long-Term Results of the RAPCO Trials. Circulation. 2020 Oct 6;142(14):1330-1338. doi: 10.1161/CIRCULATIONAHA.119.045427. Epub 2020 Oct 5.
PubMed 33017209
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Trial of Graft Patency and Clinical Outcomes, Comparing Radial Artery With Either the Right Internal Thoracic Artery or Saphenous Vein
- ClinicalTrials.gov ID
- NCT00475488
- Acronym / sponsor ID
- RAPCO / H2006/02690
- Conditions
- Coronary Artery Disease, Atherosclerosis
- Keywords
- radial artery, right internal thoracic artery, saphenous vein, grafts, coronary bypass surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 605 participants (estimated)
- Lead sponsor
- Austin HealthOther government
- Study start
- Jun 1996
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Department of Cardiac Surgery at Austin Health is conducting a prospective randomised trial, stratified into two separate sub-studies. The first compares the radial artery with the right internal thoracic artery(as a free aorto-coronary graft) and the second comparies the radial artery with a saphenous vein graft. Each patient was to be followed for 10 years after their CABG surgery in order to assess both the pattern of graft survival over 10 years and also to record major clinical events.
The study was first given approval by the Austin Health Human Research Ethics Committee on August 18th,1995. Enrolment commenced in June 1996. Recruitment ceased in March 2005. Patients were randomly assigned to the control or experimental group, patients in both groups received the left internal thoracic artery to the left anterior decending(LAD) and the study graft as the second graft.
The gold standard measure for the comparison of conduits is through the use of post-operative angiograms. These angiograms assess how patent (open) the grafts are, and also offer quality assurance of the CABG surgery performed. To spread the graft patency end-points over the 10 years after CABG, patients undergo a second randomisation as to the time at which their graft patency is to be assessed. The timing of the graft study coronary angiogram is weighted towards the end of the 10 year period with the aim of having 10% at 1 year, 20% at 2 years, 20% at 5 years, 30% at 7.5 years and 30% at 10 years after CABG surgery. Clinical data is systematically collected to determine those patients who experience heart attack, repeat surgery, balloon angioplasty or death over subsequent years.
To enrich the number of mid-study graft patency end-points a protocol amendment(July 19th, 2002) was approved allowing patients to be offered a selective coronary angiogram at the 5 year anniversary of their surgery.
A further protocol amendment(November 16th, 2006) allowed coronary and graft CT angiography to be used optionally to replace selective angiography and also to offer all patients imaging at 10 years, in addition to the original pre-specified, randomised time of imaging.
As per the ethics approval and prior protocol amendments, lifelong followup is conducted on patients enrolled in the trial. As such, a RAPCO-Extension trial will be conducted, evaluating clinical outcomes at 15-years follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Procedure: Coronary artery bypass graftingRadial Artery versus Right Internal Thoracic Artery when used as a coronary conduit in patients undergoing multi-vessel coronary artery bypass grafting. |
| Group 2 | Other | Procedure: Coronary artery bypass graftingRadial Artery versus Saphenous Vein when used as a coronary conduit in patients undergoing multi-vessel coronary artery bypass grafting. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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%.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary artery bypass graftingSurgery performed due to coronary artery disease. | Procedure or surgery | Group 1, Group 2 |
Primary outcome
Graft patency on all surviving trial patients.
Time frame: Between 1-10 years from CABG surgery.
Graft failure defined as either total occlusion, stenosis >80% or string sign.
2 secondary outcomes
All cause mortality ·
Time frame: 10 years from CABG surgery
Event free Survival
Time frame: 10 years from CABG surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Derived from this study: PubMed 33017209Buxton BF, Hayward PA, Raman J, Moten SC, Rosalion A, Gordon I, Seevanayagam S, Matalanis G, Benedetto U, Gaudino M, Hare DL; RAPCO Investigators*. Long-Term Results of the RAPCO Trials. Circulation. 2020 Oct 6;142(14):1330-1338. doi: 10.1161/CIRCULATIONAHA.119.045427. Epub 2020 Oct 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L Hare, MB BS DPM FRACP FESC FACC study director
Austin Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary artery bypass grafting in people with Coronary Artery Disease and Atherosclerosis, run by Austin Health at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft patency on all surviving trial patients. (time frame: Between 1-10 years from CABG surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00475488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2022.