Copenhagen Arterial Revascularization Randomized Patency and Outcome Trial

NCT00159991 | Unknown Phase 3

• 1 other identifier: 961502837
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Arteriosclerosis; Ischemic Heart Disease; Angina Pectoris

Keywords

Coronary artery bypass grafting; Total arterial revascularization; Internal mammary artery grafting; Radial artery grafting

Outcome Measures

Primary Outcomes (2)

• Angiographic distal anastomotic patency rates

  1, 5 and 10 years postoperatively

• Cardiac event free survival

  1, 5 and 10 years postoperatively

Secondary Outcomes (4)

• Peroperative mortality

  Until 3 months postoperatively

• 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).

  3 months postoperatively

• Risk of recurrent angina and need for antianginal medication

  1, 5 and 10 years postoperatively

• Data on functional status and social rehabilitation at clinical controls

  3 months, 1, 5 and 10 years postoperatively

Study Arms (2)

A

EXPERIMENTAL

Total arterial revascularization

Procedure: Total arterial revascularization

B

ACTIVE COMPARATOR

Conventional revascularization

Procedure: Conventional revascularization

Interventions

Total arterial revascularization PROCEDURE

Coronary artery bypass grafting using LIMA and RIMA and/or radial artery grafts

Also known as: LIMA: left internal mammary artery, RIMA: right internal mammary artery

A

Conventional revascularization PROCEDURE

Coronary artery bypass grafting using LIMA and saphenous vein grafts

Also known as: LIMA: left internal mammary artery

B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Danish Heart Foundation: collaborator
• Lundbeck Foundation: collaborator
• Copenhagen Hospital Corporation: collaborator

Study Sites (1)

Department of Cardiothoracic Surgery, Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (1)

• Damgaard S, Wetterslev J, Lund JT, Lilleor NB, Perko MJ, Kelbaek H, Madsen JK, Steinbruchel DA. One-year results of total arterial revascularization vs. conventional coronary surgery: CARRPO trial. Eur Heart J. 2009 Apr;30(8):1005-11. doi: 10.1093/eurheartj/ehp048. Epub 2009 Mar 6.

  PMID: 19270315 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sune Damgaard, MD

  Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen

  PRINCIPAL INVESTIGATOR

• Daniel A Steinbrüchel, Professor

  Dept. of Cardiothoracic Surgery, Rigshospitalet, Copenhagen

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: February 1, 2002
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2015
• Last Updated: February 15, 2008

Record last verified: 2008-01

Locations

DK (1)