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

Sponsor
Region Örebro County (Other)
Overall Status
Recruiting
CT.gov ID
NCT04656366
Collaborator
(none)
1,000
1
15
66.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Coronary Angiography

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Coronary Angiographical Results in Patients With Angina After CABG: Comparison Between No-touch and Conventional Vein Graft
Actual Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
No-touch

Participants that operated at the time of the coronary artery bypass grafting with a "no-touch" venous graft.

Diagnostic Test: Coronary Angiography
Diagnostic Coronary angiography for patients that presented angina after a previous CABG operation; eventually interventional procedure with PCI (Percutaneous Coronary Intervention)
Other Names:
  • Previously: coronary artery bypass grafting (CABG)
  • Conventional

    Participants that operated at the time of the coronary artery bypass grafting with a "conventional" venous graft.

    Diagnostic Test: Coronary Angiography
    Diagnostic Coronary angiography for patients that presented angina after a previous CABG operation; eventually interventional procedure with PCI (Percutaneous Coronary Intervention)
    Other Names:
  • Previously: coronary artery bypass grafting (CABG)
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Rate of MACE [after the primary CABG (until June the 30th 2020)]

      major adverse cardiac events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kärl-Thoraxkliniken; University Hospital of Örebro Örebro Sweden 70185

    Sponsors and Collaborators

    • Region Örebro County

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Gabriele Ferrari, Principal Investigator, Region Örebro County
    ClinicalTrials.gov Identifier:
    NCT04656366
    Other Study ID Numbers:
    • OLL-274418
    First Posted:
    Dec 7, 2020
    Last Update Posted:
    Dec 8, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Gabriele Ferrari, Principal Investigator, Region Örebro County

    Study Results

    No Results Posted as of Dec 8, 2020