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CT-angiographic Follow up of Patients That Underwent Coronary Bypass Surgery Between 1993-1997

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
No touch technique
Conventional technique
Sponsored by
Örebro County Council
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery bypass grafting, Saphenous vein grafts

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. First time coronary artery bypass grafting with either conventional or no touch vein grafts performed by Dr.Souza between 1993-1997.
  2. Included in the previous follow up studies
  3. Signed and dated consent.

Exclusion Criteria:

  1. Allergy to contrast
  2. Renal failure
  3. Uncontrolled diabetes
  4. Unable to implement the study according to protocol -

Sites / Locations

  • Department for Cardiovascular and Thoracic Surgery, Örebro University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

No touch vein grafts

Conventional vein grafts.

Arm Description

The grafts were harvested with there surrounding tissues.

The grafts were stripped from surrounding tissue.

Outcomes

Primary Outcome Measures

Patency of the grafts

Secondary Outcome Measures

Stenosis in the grafts.

Full Information

First Posted
September 12, 2012
Last Updated
September 18, 2012
Sponsor
Örebro County Council
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1. Study Identification

Unique Protocol Identification Number
NCT01686100
Brief Title
CT-angiographic Follow up of Patients That Underwent Coronary Bypass Surgery Between 1993-1997
Official Title
CT-angiographic Follow Upp of Patients That Underwent Coronary Bypass Surgery Between 1993-1997. A Randomized Longitudinal Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Örebro County Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Coronary artery surgery (CABG) is necessary to improve blood circulation in many patients with coronary artery disease. This is done by using alternative blood vessels (grafts) to bypass the stenosed coronary arteries. In CABG, vein grafts are traditionally used where surrounding tissue is removed, this may damage the vessel and influence its patency. The "no-touch" technique was developed by Professor Domingos Souza at the Department of Cardiovascular and Thoracic Surgery, Örebro University Hospital. This technique includes taking out the vein with its surrounding tissue and by this way the vessel is less damaged. The first two follow ups have shown that no-touch grafts had better patency than conventionally extracted graft at 18 months and 8.5 years. This long term follow up is a continuation of the randomized trial started in 1993 where the patency and incidence of stenoses in the no touch and conventional vein grafts has been studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery bypass grafting, Saphenous vein grafts

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No touch vein grafts
Arm Type
Active Comparator
Arm Description
The grafts were harvested with there surrounding tissues.
Arm Title
Conventional vein grafts.
Arm Type
Active Comparator
Arm Description
The grafts were stripped from surrounding tissue.
Intervention Type
Procedure
Intervention Name(s)
No touch technique
Intervention Description
The vein graft is harvested with its surronding tissues.
Intervention Type
Procedure
Intervention Name(s)
Conventional technique
Intervention Description
The vein graft is stripped from its surrounding tissues.
Primary Outcome Measure Information:
Title
Patency of the grafts
Time Frame
Mean time of 15 years.
Secondary Outcome Measure Information:
Title
Stenosis in the grafts.
Time Frame
Mean time of 15 years.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First time coronary artery bypass grafting with either conventional or no touch vein grafts performed by Dr.Souza between 1993-1997. Included in the previous follow up studies Signed and dated consent. Exclusion Criteria: Allergy to contrast Renal failure Uncontrolled diabetes Unable to implement the study according to protocol -
Facility Information:
Facility Name
Department for Cardiovascular and Thoracic Surgery, Örebro University Hospital
City
Örebro
ZIP/Postal Code
70185
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
16872965
Citation
Souza DS, Johansson B, Bojo L, Karlsson R, Geijer H, Filbey D, Bodin L, Arbeus M, Dashwood MR. Harvesting the saphenous vein with surrounding tissue for CABG provides long-term graft patency comparable to the left internal thoracic artery: results of a randomized longitudinal trial. J Thorac Cardiovasc Surg. 2006 Aug;132(2):373-8. doi: 10.1016/j.jtcvs.2006.04.002.
Results Reference
background
PubMed Identifier
17462310
Citation
Loesch A, Dashwood MR, Souza DS. Does the method of harvesting the saphenous vein for coronary artery bypass surgery affect venous smooth muscle cells? iNOS immunolabelling and ultrastructural findings. Int J Surg. 2006;4(1):20-9. doi: 10.1016/j.ijsu.2005.11.002. Epub 2006 Jan 3.
Results Reference
background
PubMed Identifier
21051379
Citation
Dashwood MR, Dooley A, Shi-Wen X, Abraham DJ, Dreifaldt M, Souza DS. Perivascular fat-derived leptin: a potential role in improved vein graft performance in coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2011 Feb;12(2):170-3. doi: 10.1510/icvts.2010.247874. Epub 2010 Nov 3.
Results Reference
background
PubMed Identifier
20381817
Citation
Dreifaldt M, Souza DS, Loesch A, Muddle JR, Karlsson MG, Filbey D, Bodin L, Norgren L, Dashwood MR. The "no-touch" harvesting technique for vein grafts in coronary artery bypass surgery preserves an intact vasa vasorum. J Thorac Cardiovasc Surg. 2011 Jan;141(1):145-50. doi: 10.1016/j.jtcvs.2010.02.005. Epub 2010 Apr 9.
Results Reference
background
PubMed Identifier
20362457
Citation
Johansson BL, Souza DS, Bodin L, Filbey D, Loesch A, Geijer H, Bojo L. Slower progression of atherosclerosis in vein grafts harvested with 'no touch' technique compared with conventional harvesting technique in coronary artery bypass grafting: an angiographic and intravascular ultrasound study. Eur J Cardiothorac Surg. 2010 Oct;38(4):414-9. doi: 10.1016/j.ejcts.2010.02.007. Epub 2010 Apr 1.
Results Reference
background
PubMed Identifier
18609044
Citation
Johansson BL, Souza DS, Bodin L, Filbey D, Bojo L. No touch vein harvesting technique for CABG improves the long-term clinical outcome. Scand Cardiovasc J. 2009 Feb;43(1):63-8. doi: 10.1080/14017430802140104.
Results Reference
background
PubMed Identifier
18592087
Citation
Rueda Fd, Souza D, Lima Rde C, Menezes A, Johansson B, Dashwood M, The E, Gesteira M, Escobar M, Vasconcelos F. Novel no-touch technique of harvesting the saphenous vein for coronary artery bypass grafting. Arq Bras Cardiol. 2008 Jun;90(6):356-62. doi: 10.1590/s0066-782x2008000600002. English, Portuguese.
Results Reference
background
PubMed Identifier
16122459
Citation
Dashwood MR, Savage K, Dooley A, Shi-Wen X, Abraham DJ, Souza DS. Effect of vein graft harvesting on endothelial nitric oxide synthase and nitric oxide production. Ann Thorac Surg. 2005 Sep;80(3):939-44. doi: 10.1016/j.athoracsur.2005.03.042.
Results Reference
background
PubMed Identifier
15838269
Citation
Dashwood M, Anand R, Loesch A, Souza D. Surgical trauma and vein graft failure: further evidence for a role of ET-1 in graft occlusion. J Cardiovasc Pharmacol. 2004 Nov;44 Suppl 1:S16-9. doi: 10.1097/01.fjc.0000166222.50346.c6.
Results Reference
background
PubMed Identifier
11996262
Citation
Souza DS, Dashwood MR, Tsui JC, Filbey D, Bodin L, Johansson B, Borowiec J. Improved patency in vein grafts harvested with surrounding tissue: results of a randomized study using three harvesting techniques. Ann Thorac Surg. 2002 Apr;73(4):1189-95. doi: 10.1016/s0003-4975(02)03425-2.
Results Reference
background
PubMed Identifier
11854735
Citation
Tsui JC, Souza DS, Filbey D, Karlsson MG, Dashwood MR. Localization of nitric oxide synthase in saphenous vein grafts harvested with a novel "no-touch" technique: potential role of nitric oxide contribution to improved early graft patency rates. J Vasc Surg. 2002 Feb;35(2):356-62. doi: 10.1067/mva.2002.121072.
Results Reference
background
PubMed Identifier
11531869
Citation
Tsui JC, Souza DS, Filbey D, Bomfim V, Dashwood MR. Preserved endothelial integrity and nitric oxide synthase in saphenous vein grafts harvested by a 'no-touch' technique. Br J Surg. 2001 Sep;88(9):1209-15. doi: 10.1046/j.0007-1323.2001.01855.x.
Results Reference
background
PubMed Identifier
10622542
Citation
Souza DS, Christofferson RH, Bomfim V, Filbey D. "No-touch" technique using saphenous vein harvested with its surrounding tissue for coronary artery bypass grafting maintains an intact endothelium. Scand Cardiovasc J. 1999;33(6):323-9. doi: 10.1080/14017439950141362.
Results Reference
background
PubMed Identifier
8727856
Citation
Souza D. A new no-touch preparation technique. Technical notes. Scand J Thorac Cardiovasc Surg. 1996;30(1):41-4. doi: 10.3109/14017439609107239. No abstract available.
Results Reference
background
PubMed Identifier
26282605
Citation
Samano N, Geijer H, Liden M, Fremes S, Bodin L, Souza D. The no-touch saphenous vein for coronary artery bypass grafting maintains a patency, after 16 years, comparable to the left internal thoracic artery: A randomized trial. J Thorac Cardiovasc Surg. 2015 Oct;150(4):880-8. doi: 10.1016/j.jtcvs.2015.07.027. Epub 2015 Jul 15.
Results Reference
derived
PubMed Identifier
25852948
Citation
Johansson B, Samano N, Souza D, Bodin L, Filbey D, Mannion JD, Bojo L. The no-touch vein graft for coronary artery bypass surgery preserves the left ventricular ejection fraction at 16 years postoperatively: long-term data from a longitudinal randomised trial. Open Heart. 2015 Mar 24;2(1):e000204. doi: 10.1136/openhrt-2014-000204. eCollection 2015.
Results Reference
derived

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CT-angiographic Follow up of Patients That Underwent Coronary Bypass Surgery Between 1993-1997

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