Radial Artery Graft Patency Study - Full Text View

Sponsors and Collaborators:	Austin Health St Vincent
Information provided by:	Austin Health
ClinicalTrials.gov Identifier:	NCT00475488

Purpose

Coronary Artery Bypass Graft Surgery (CABGS) 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, the saphenous veins from the legs and internal thoracic arteries from behind the breastbone 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 best conduits to use.

It has been suggested that the radial arteries might function better than saphenous veins as conduits. The Radial Artery Graft Study aims to compare patency of the radial arteries with saphenous veins and the right internal thoracic artery.

Condition	Intervention
Coronary Artery Disease Atherosclerosis	Procedure: coronary angiogram or multi slice computed tomography scan

MedlinePlus related topics: Chest Pain Coronary Artery Bypass Surgery Coronary Artery Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Department of Cardiac Surgery at Austin Health is Conducting a Prospective Randomised Trial, Comparing the Performance of the Radial Artery With the Currently Used Grafts in Patients Requiring Coronary Artery Bypass Grafts.

Further study details as provided by Austin Health:

Primary Outcome Measures:

Graft patency will be assessed by angiography. 60% of patients will be catheterised between 7-10 years post surgery. [ Time Frame: 10 years from initial enrolment into the study ]

Secondary Outcome Measures:

Clinical · Onset of ischaemic chest pain · Acute myocardial infarct · Re-operation: coronary artery bypass grafting · Angioplasty · Stenting · Death [ Time Frame: 10 years from initial enrolment into the study ]

Enrollment:	619
Study Start Date:	June 1996
Estimated Study Completion Date:	March 2015

Detailed Description:

The Department of Cardiac Surgery at Austin Health is conducting a prospective randomised trial, comparing the performance of the radial artery with the right internal mammary artery and the saphenous vein graft, in patients requiring coronary artery bypass surgery.

The study was first given approval by the Austin Health Human Research Ethics Committee in 1995 for a ten-year period. Enrolment commenced in March 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 as their first graft. Those in the control group received either a right internal thoracic artery or saphenous vein graft as their second graft. Those in the experimental group received a radial artery graft as their 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. The angiograms are randomly allocated/ scheduled at 1, 2, 5, 7.5 or 10 years after bypass surgery.Participants are also offered an elective coronary angiogram (or a Multi slice CT coronary angiogram scan, should they refuse the standard coronary angiogram) at 5 & 10 years after their surgery. Clinical data is systematically collected to determine those patients who experience heart attack, repeat surgery, balloon angioplasty or death over subsequent years.

Eligibility

Ages Eligible for Study:	36 Years to 83 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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
Other patients <70

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475488

Locations

Australia, Victoria
Austin Health
Melbourne, Victoria, Australia, 3084

Sponsors and Collaborators

Austin Health

St Vincent

Investigators

Principal Investigator:

Brian Buxton, surgery

Austin Health

More Information

Publications of Results:

Buxton BF, Raman JS, Ruengsakulrach P, Gordon I, Rosalion A, Bellomo R, Horrigan M, Hare DL. Radial artery patency and clinical outcomes: five-year interim results of a randomized trial. J Thorac Cardiovasc Surg. 2003 Jun;125(6):1363-71.

Study ID Numbers:	H2006/02690
Study First Received:	May 17, 2007
Last Updated:	May 17, 2007
ClinicalTrials.gov Identifier:	NCT00475488
Health Authority:	Australia: Human Research Ethics Committee

Keywords provided by Austin Health:

radial
artery
grafts
bypass
surgery

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Atherosclerosis
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Ischemia
Arteriosclerosis
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009