NCT03231527

Brief Summary

"real-life" retrospective multicentric database for the analysis of the long term outcomes of total arterial CABG in comparison to saphenous vein based CABG

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2017

Geographic Reach
4 countries

4 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

July 13, 2020

Status Verified

July 1, 2020

Enrollment Period

1.7 years

First QC Date

July 24, 2017

Last Update Submit

July 9, 2020

Conditions

Coronary Artery DiseaseSurgical Wound Infection

Outcome Measures

Primary Outcomes (4)

  • Survival

    Long term survival

    data collection every year up to 5 years after operation/entry in the registry

  • MACCEs

    Major cardiac events (myocardial infarction, stroke, readmission for CHF)

    data collection every year up to 5 years after operation/entry in the registry

  • target vessel revascularization

    readmission for revascularization due to graft failure

    data collection every year up to 5 years after operation/entry in the registry

  • Wound infection

    Readmission for wound infection (superficial sternal wound infection, deep sternal wound infection, saphenous vein related wound infection, need for VAC therapy, need for surgical debridment, need for prolonged antibiotic therapy)

    data collection every year up to 5 years after operation/entry in the registry

Secondary Outcomes (9)

  • Blood product usage

    perioperative (in hospital)

  • Bleeding

    perioperative (in hospital)

  • Length of ICU stay

    perioperative (in hospital)

  • Length of hospital stay

    perioperative (in hospital)

  • Duration of ventilation

    perioperative (in hospital)

  • +4 more secondary outcomes

Study Arms (2)

Total Arterial coronary CABG

Total Arterial revascularization

Procedure: coronary artery bypass grafting (CABG)

Saphenous vein based CABG

Saphenous vein based revascularization

Procedure: coronary artery bypass grafting (CABG)

Interventions

coronary artery bypass grafting (CABG)PROCEDURE

myocardial revascularization

Saphenous vein based CABGTotal Arterial coronary CABG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary elective isolated CABG from multivessel coronary artery disease (CAD

You may qualify if:

  • elective CABG patients (on pump or off pump surgery; pedicles of skletonized internal mammary artery harvesting technique; open or endoscopic vein harvesting technique)

You may not qualify if:

  • urgent or emergent CABG
  • concomitant procedures
  • redo cases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Campus St Ian

Genk, Belgium

Location

University Campus Bio-Medico

Rome, Italy

Location

Thoracic Centrum Twente

Enschede, Netherlands

Location

Golden Jubilee National Hospital

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Coronary Artery DiseaseSurgical Wound Infection

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesWound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Officials

  • Cristiano Spadaccio, MD, PhD

    Golden Jubilee National Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiothoracic surgeon

Study Record Dates

First Submitted

July 24, 2017

First Posted

July 27, 2017

Study Start

February 1, 2017

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

July 13, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)IT(1)GB(1)BE(1)