Impact of Cholesterol Level on Long-term Coronary Bypass Graft Patency

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05393882
Collaborator
(none)
200
52

Study Details

Study Description

Brief Summary

This single-centre cross-sectional study aims to ascertain the impact of dyslipidemia on long-term graft patency after coronary artery bypass grafting (CABG).

Detailed Description

All consecutive patients who underwent CABG from 1st January 2007 to 31st December 2008 at the Prince of Wales Hospital were eligible for entry.

Graft patency will be determined by computed tomography coronary angiogram. The severity of stenosis will be classified by the Fitzgibbon classification system.

The levels of individual lipid profile subcomponents, namely LDL-C, high-density lipoprotein cholesterol (HDL-C), total cholesterol and triglycerides (TG) will be obtained. A plot of lipid profile subcomponent measurements against time will be compiled and the area under the curve is calculated to estimate gross exposure after CABG. Average lipid exposure is calculated by dividing the gross exposure by the number of days lapsed between the first and last lipid profile measurements.

The association between average cholesterol target attainment and graft patency will then be determined.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Impact of Cholesterol Level on Long-term Angiographic Outcome of Coronary Artery Bypass Grafting
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2025
Anticipated Study Completion Date :
Dec 31, 2026

Outcome Measures

Primary Outcome Measures

  1. Graft patency [Immediately after CTCA]

    Graft patency as assessed by computed tomographic coronary angiogram, using Fitzgibbon classification

Secondary Outcome Measures

  1. Actuarial cardiac events [Immediately after CTCA]

    Events attributable to cardiac causes as adjudicated by the investigators, including congestive heart failure, ischaemic cardiomyopathy, myocardial infarction, ventricular arrhythmias, recurrent angina

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All consecutive patients on record who underwent coronary artery bypass graft surgery in 2007 and 2008
Exclusion Criteria:
  • Death

  • Single vessel LIMA-LAD anastomosis only

  • Concomitant valve and aortic procedures

  • Concomitant repair of post-infarct ventricular septal rupture

  • Defaulted follow-up

  • Informed consent cannot be obtained

  • Intermediate to high risk for contrast nephropathy, defined as estimated glomerular filtration rate less than 45 ml/min/1.73m2 or serum creatinine level <1.5 mg/dL (based on American College of Radiology criteria for diagnostic computed tomography risk)

  • Pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chinese University of Hong Kong

Investigators

  • Principal Investigator: Randolph HL Wong, FRCS, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Randolph Wong, Prof. Randolph Wong Hung Leung, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05393882
Other Study ID Numbers:
  • CRE Ref no. 2022.134
First Posted:
May 26, 2022
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
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 Randolph Wong, Prof. Randolph Wong Hung Leung, Chinese University of Hong Kong
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 26, 2022