- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00475488
Radial Artery Patency and Clinical Outcomes Trial (RAPCO)
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).
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Victoria
-
Melbourne, Victoria, Australia, 3084
- Austin Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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%.
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Surgery performed due to coronary artery disease.
|
Other: Group 2
Radial Artery versus Saphenous Vein when used as a coronary conduit in patients undergoing multi-vessel coronary artery bypass grafting.
|
Surgery performed due to coronary artery disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Between 1-10 years from CABG surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All cause mortality ·
Time Frame: 10 years from CABG surgery
|
Clinical follow-up and Australian National Death Registry
|
10 years from CABG surgery
|
Event free Survival
Time Frame: 10 years from CABG surgery
|
Events defined as all-cause mortality, myocardial infarction, revascularisation (percutaneous or surgical).
|
10 years from CABG surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
[RAPCO-Extension trial] All cause mortality
Time Frame: 15 years from CABG Surgery
|
Clinical follow-up
|
15 years from CABG Surgery
|
[RAPCO-Extension trial] Event free survival
Time Frame: 15 years from CABG surgery
|
Events defined as all-cause mortality, myocardial infarction, revascularisation (adjudication of all events)
|
15 years from CABG surgery
|
[RAPCO-Extension trial] Myocardial infarction
Time Frame: 15 years from CABG surgery
|
Rates of myocardial infarction (adjudication according to the fourth universal definition of MI)
|
15 years from CABG surgery
|
[RAPCO-Extension trial] Revascularisation
Time Frame: 15 years from CABG surgery
|
Rates of coronary revascularisation (either PCI or redo-CABG)
|
15 years from CABG surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: David L Hare, MB BS DPM FRACP FESC FACC, Austin Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2006/02690
- V1111-1166-3083 (Other Identifier: UTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
San Luigi Gonzaga HospitalRecruitingCoronary Disease | STEMI | Coronary Artery Ectasia | Right Coronary Artery Occlusion | Right Coronary Artery StenosisSpain, Italy
Clinical Trials on Coronary artery bypass grafting
-
University of OuluKarolinska Institutet; Universita di Verona; University of Campania "Luigi Vanvitelli... and other collaboratorsRecruitingMyocardial Infarction | Coronary Artery Disease | Angina PectorisFinland
-
University of WuerzburgDeutsche Stiftung für HerzforschungUnknownStroke | Coronary Heart Disease | Cerebral InfarctionGermany
-
University Medical Center GroningenUnknownCoronary Artery Bypass | Cognitive DysfunctionNetherlands
-
Cliniques universitaires Saint-Luc- Université...Completed
-
Far Eastern Memorial HospitalCompletedCoronary Artery Disease
-
Tomsk National Research Medical Center of the Russian...Russian Science FoundationRecruitingCoronary Artery Disease | Heart FailureRussian Federation
-
Armed Forces Institute of Cardiology, PakistanCompleted
-
Region Örebro CountySwedish Heart Lung Foundation; Regional Clinical ResearchCompleted
-
German Off Pump Coronary Artery Bypass in Elderly...Institut für Klinisch-Kardiovaskuläre Forschung GmbH; Deutsche Gesellschaft...Completed
-
Centro Cardiologico MonzinoUnknownAtherosclerosis | Myocardial RevascularizationItaly