Copenhagen Arterial Revascularization Randomized Patency and Outcome Trial - Full Text View

Purpose

There is a remarkable lack of randomized trials concerning the potential benefit of using arterial conduits for coronary bypass surgery. This is the purpose of the present trial. Exclusive use of arterial conduits might result in improved conduit viability, reduced risk of recurrent angina, myocardial infarction and other cardiac events, reduced need for antianginal medication, improved functional status and possibly improved long term survival. The patients will be followed for ten years after surgery.

Condition	Intervention	Phase
Coronary Arteriosclerosis Ischemic Heart Disease Angina Pectoris	Procedure: Total arterial revascularization Procedure: Conventional revascularization	Phase III

MedlinePlus related topics:

Angina Coronary Artery Bypass Surgery Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Arterial Revascularization for Coronary Bypass Surgery: A Randomized Trial Comparing the Outcome After Using LIMA + Vein Grafts Versus Total Arterial Revascularization With LIMA + RIMA + Radial Artery Grafts

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:

Angiographic distal anastomotic patency rates [ Time Frame: 1, 5 and 10 years postoperatively ] [ Designated as safety issue: No ]
Cardiac event free survival [ Time Frame: 1, 5 and 10 years postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Peroperative mortality [ Time Frame: Until 3 months postoperatively ] [ Designated as safety issue: Yes ]
Postoperative morbidity (frequency of peroperative/ postoperative infarction, arrythmias, use of IABP, inotropic support, pulmonary, renal and cerebral complications, length of stay in the ICU, etc. according to registration schemes). [ Time Frame: 3 months postoperatively ] [ Designated as safety issue: Yes ]
Risk of recurrent angina and need for antianginal medication [ Time Frame: 1, 5 and 10 years postoperatively ] [ Designated as safety issue: No ]
Data on functional status and social rehabilitation at clinical controls [ Time Frame: 3 months, 1, 5 and 10 years postoperatively ] [ Designated as safety issue: No ]

Enrollment:	331
Study Start Date:	February 2002
Estimated Study Completion Date:	February 2015
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Total arterial revascularization	Procedure: Total arterial revascularization Coronary artery bypass grafting using LIMA and RIMA and/or radial artery grafts
B: Active Comparator Conventional revascularization	Procedure: Conventional revascularization Coronary artery bypass grafting using LIMA and saphenous vein grafts

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Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with 2 or 3 vessel coronary artery disease, where more than 1 coronary bypass graft is anticipated.
Elective or subacute operation (unstable AP with surgery within a few days)
Inclusion is independent of ventricular function, recent MI, degree and type of coronary lesions and secondary risk factors as diabetes, hyperlipidemia, hypertension, lung function, chronic obstructive lung disease, peripheral atherosclerotic disease, kidney function, earlier cerebrovascular disease.
Age: < 70 years.
Sufficient collateral blood supply to the hand by the ulnar artery, evaluated by the Allen test.
Patients must be able to give informed consent.

Exclusion Criteria:

Concurrent malignant disease with expected survival of < 5 years.
Unsuitable saphenous vein grafts evaluated preoperatively.
Unsuitable saphenous vein grafts with a diameter > 6mm evaluated preoperatively.
Acute operation (unstable hemodynamics in terms of need of inotropic support, ongoing MI with dynamic ECG changes, cardiogenic shock).
Concommitant operation for valve disease or other forms of heart surgery. Redo operations.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00159991

Locations


Denmark
	Department of Cardiothoracic Surgery, Rigshospitalet
	Copenhagen, Denmark, 2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Danish Heart Foundation

The Lundbeck Foundation

Copenhagen Hospital Corporation

Investigators


Principal Investigator:	Sune Damgaard, MD	Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen

Study Director:	Daniel A Steinbrüchel, Professor	Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen

Study Chair:	Jens T Lund, Consultant	Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen

Study Chair:	Henning Kelbæk, Consultant	Cardiac Cath. Lab., Rigshospitalet, Copenhagen

Study Chair:	Jan K Madsen, Consultant	Dept. of Cardiology, Gentofte County Hospital, Copenhagen

More Information

Responsible Party:	Department of Cardiothoracic Surgery, Rigshospitalet ( Sune Damgaard MD )
Study ID Numbers:	961502837
First Received:	September 8, 2005
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00159991
Health Authority:	Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:

Coronary artery bypass grafting

Total arterial revascularization

Internal mammary artery grafting

Radial artery grafting

Study placed in the following topic categories:

Coronary Disease

Arterial Occlusive Diseases

Signs and Symptoms

Heart Diseases

Myocardial Ischemia

Vascular Diseases

Angina Pectoris

Pain

Ischemia

Arteriosclerosis

Coronary Artery Disease

Chest Pain

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Rigshospitalet, Denmark Danish Heart Foundation The Lundbeck Foundation Copenhagen Hospital Corporation
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00159991