Results of Coronary Angiography Rafter CABG: Comparison Between No-touch and Conventional Vein Graft

• Conditions: Bypass Graft Stenosis
• Interventions: Diagnostic Test: Coronary Angiography

• Registration Number: NCT04656366
• Lead Sponsor: Region Örebro County

Brief Summary

Coronary artery disease is one of the biggest health issue worldwide: It is estimated that cardiovascular diseases cause around 45% of all death in Sweden and in the West World. The treatment, in a large part of the patients, implicates a so called bypass-operation, that consists in to connect new vascular conduits (grafts) beyond the narrowed coronary vessels to improve the blood supply to the heart. One of the graft that is commonly used is the saphenous vein from the leg. The disadvantage of the saphenous vein graft is the predisposition to early obstruction. The international literature shows the following grades of occlusion: 15% in the first year and 40% after 10 years.

At the Cardio-Thoracic Clinic of the University hospital of Örebro has been developed a new method to harvest the saphenous vein together with the surrounding fat-tissue. This technique, called no-touch technique, has the advantage to reduce the damages to the vein during the harvesting, showing a substantially reduced risk for future occlusion (5% after 18 months and 10% after 8,5 years).

2020-05-20 2020-11-16 Project created in: FoU Region Örebro län Resultat av Koronarangiografi hos patienter som tidigare CABG opererats Project number : 274418 Created by: Gabriele Ferrari, 2020-05-20 Last revised by: Gabriele Ferrari, 2020-11-16 Ongoing The aim of the PhD project is to evaluate the results of the no-touch technique in compare to the conventional technique for the venous graft harvesting. The focus of the study is to analyze all the operated patients in our clinic who underwent a post-operative coronary angiography do to angina pectoris (heart pain). One will compare the patency rate, the rate of MACE (major adverse cardiac events) and the quality of life in the two groups (no-touch vs. conventional). This study is the first and the only one in the world that will examine the long-term angiographic results of the no-touch technique in patients that had angina pectoris after the operation.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-01
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-11-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-04
• Study First Posted: 2020-12-07
• Last Update Posted: 2020-12-08
• Primary Completion: 2021-12-01
• Study Completion: 2022-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Angina after CABG requiring diagnostic coronary angiography
• CABG operation between 1992 and June 30th 2020
• Coronary angiography between 2006 and June 30th 2020

Exclusion Criteria

• Coronary angiography within 30 days from the CABG operation date

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Conventional	Coronary Angiography	Participants that operated at the time of the coronary artery bypass grafting with a "conventional" venous graft.
No-touch	Coronary Angiography	Participants that operated at the time of the coronary artery bypass grafting with a "no-touch" venous graft.

Primary Outcome Measures

Name	Time	Method
Rate of Graft Patency	after the primary CABG (until June the 30th 2020)	Grade of freedom from stenosis in the saphenous vein graft used during the primary CABG

Secondary Outcome Measures

Name	Time	Method
Rate of MACE	after the primary CABG (until June the 30th 2020)	major adverse cardiac events

Trial Locations

Locations (1)

Kärl-Thoraxkliniken; University Hospital of Örebro; 🇸🇪 Örebro, Sweden