Clinical trial NCT03231527: Outcomes of Total Arterial Coronary Artery Bypass Grafting
Official title: Multicentric Registry Database of Total Arterial CABG
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease
Surgical Wound Infection
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: Campus Bio-Medico University
name: Universitaire Ziekenhuizen KU Leuven
name: Thorax Centrum Twente
name: Golden Jubilee National Hospital
First posted: 2017-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary elective isolated CABG from multivessel coronary artery disease (CAD

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

Detailed description: This aim of this registry is to create a multi centric database for the analysis of basic long term outcomes and immediate postoperative outcomes of total arterial CABG in comparison to saphenous vein based CABG. The registry will include both on pump and off pump surgery. The registry is intended to capture the "real-life" picture of the CABG scenario among centers worldwide

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* urgent or emergent CABG
* concomitant procedures
* redo cases

Primary outcomes:
measure: Survival
timeFrame: data collection every year up to 5 years after operation/entry in the registry
measure: MACCEs
timeFrame: data collection every year up to 5 years after operation/entry in the registry
measure: target vessel revascularization
timeFrame: data collection every year up to 5 years after operation/entry in the registry
measure: Wound infection
timeFrame: data collection every year up to 5 years after operation/entry in the registry
Secondary outcomes:
measure: Blood product usage
timeFrame: perioperative (in hospital)
measure: Bleeding
timeFrame: perioperative (in hospital)
measure: Length of ICU stay
timeFrame: perioperative (in hospital)
measure: Length of hospital stay
timeFrame: perioperative (in hospital)
measure: Duration of ventilation
timeFrame: perioperative (in hospital)
measure: Cardiac complication
timeFrame: perioperative (in hospital)
measure: Respiratory complications
timeFrame: perioperative (in hospital)
measure: Renal complications
timeFrame: perioperative (in hospital)
measure: GI complications
timeFrame: perioperative (in hospital)
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Campus St Ian
city: Rome
country: Italy
facility: University Campus Bio-Medico
city: Enschede
country: Netherlands
facility: Thoracic Centrum Twente
city: Glasgow
country: United Kingdom
facility: Golden Jubilee National Hospital
Study officials:
affiliation: Golden Jubilee National Hospital
name: Cristiano Spadaccio, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: