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WithdrawnNCT05393882Updated Mar 6, 2025

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

An observational study in Coronary Artery Disease, Bypass Graft Stenosis and Dyslipidemias, sponsored by Chinese University of Hong Kong. Withdrawn at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-06.

Sponsored by Chinese University of Hong Kong · Observational

Why this study was withdrawn
Insufficient funding
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Coronary Artery Disease
  • Bypass Graft Stenosis
  • Dyslipidemias
  • Bypass Graft Occlusion
  • Coronary Bypass Graft Stenosis
  • Coronary Artery Stenosis
  • Hyperlipidemia
  • Hypercholesterolemia

Keywords

  • Bypass graft failure
  • Dyslipidemia
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

Browse Coronary Artery Disease studies →

Lead sponsor

Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All living consecutive patients on record who underwent isolated coronary artery bypass graft surgery in 2007 and 2008 at Prince of Wales Hospital were eligible for participation. Patients were excluded if they were at high risk of contrast nephropathy.

Inclusion criteria

  • All consecutive patients on record who underwent coronary artery bypass graft surgery in 2007 and 2008

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
0 participants (actual)
Target follow-up
15 Years
Patient registry
Yes

Interventions

  • RadiationComputed tomography coronary angiogram

    Preparation * Rate control with oral beta-blockers or calcium channel blockers to achieve the target heart rate of 60 to 70 beats per minute * Sublingual Nitroglycerin to be given on table if not contraindicated, 5 minutes prior to scanning * 18G angiocath at a large antecubital vein for intravenous contrast injection Scanning procedure Contrast CT angiogram (Retrospective gating) * Contrast medium and injection protocol: 75ml Omnipaque 350 with 50ml saline chaser * Automatic triggering started at the aorta of the level of left main coronary artery when the relative reached 100 * Scanning coverage: From the thoracic inlet to diaphragm

06

What researchers measure

Primary outcomes

  1. Graft patency

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

    Time frame: Immediately after CTCA

Secondary outcomes

  1. Actuarial cardiac events

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

    Time frame: Immediately after CTCA

07

Study locations

1 site
  • Prince of Wales Hospital
    Hong Kong, Hong Kong
08

References and documents

Publications

  • Kulik A, Brookhart MA, Levin R, Ruel M, Solomon DH, Choudhry NK. Impact of statin use on outcomes after coronary artery bypass graft surgery. Circulation. 2008 Oct 28;118(18):1785-92. doi: 10.1161/CIRCULATIONAHA.108.799445. Epub 2008 Oct 13. PubMed 18852363 ↗
  • Knatterud GL, Rosenberg Y, Campeau L, Geller NL, Hunninghake DB, Forman SA, Forrester JS, Gobel FL, Herd JA, Hickey A, Hoogwerf BJ, Terrin ML, White C. Long-term effects on clinical outcomes of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation in the post coronary artery bypass graft trial. Post CABG Investigators. Circulation. 2000 Jul 11;102(2):157-65. doi: 10.1161/01.cir.102.2.157. PubMed 10889125 ↗
  • Li Z, Qiao Y, Sheng W, Chi Y. Newly Developed Graft Failure Detected Using Computed Tomography Within 1 Year After Coronary Artery Bypass Grafting Surgery: One Single-Center Experience. Front Cardiovasc Med. 2022 Jan 31;9:779015. doi: 10.3389/fcvm.2022.779015. eCollection 2022. PubMed 35174230 ↗
  • Niclauss L. Techniques and standards in intraoperative graft verification by transit time flow measurement after coronary artery bypass graft surgery: a critical review. Eur J Cardiothorac Surg. 2017 Jan;51(1):26-33. doi: 10.1093/ejcts/ezw203. Epub 2016 Jun 13. PubMed 27298393 ↗
  • Farooq V, Girasis C, Magro M, Onuma Y, Morel MA, Heo JH, Garcia-Garcia H, Kappetein AP, van den Brand M, Holmes DR, Mack M, Feldman T, Colombo A, Stahle E, James S, Carrie D, Fournial G, van Es GA, Dawkins KD, Mohr FW, Morice MC, Serruys PW. The CABG SYNTAX Score - an angiographic tool to grade the complexity of coronary disease following coronary artery bypass graft surgery: from the SYNTAX Left Main Angiographic (SYNTAX-LE MANS) substudy. EuroIntervention. 2013 Mar;8(11):1277-85. doi: 10.4244/EIJV8I11A196. PubMed 23537954 ↗
  • Karolyi M, Eberhard M, Gloor T, Polacin M, Manka R, Savic V, Plass AR, Vogt PR, Alkadhi H, Schmiady MO. Routine early postoperative computed tomography angiography after coronary artery bypass surgery: clinical value and management implications. Eur J Cardiothorac Surg. 2022 Jan 24;61(2):459-466. doi: 10.1093/ejcts/ezab390. PubMed 34410332 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05393882
Lead sponsor
Chinese University of Hong Kong
Responsible party
Randolph Wong (Prof. Randolph Wong Hung Leung, Chinese University of Hong Kong) — Principal investigator
First posted
May 26, 2022
Start date
Sep 2025 (estimated)
Primary completion
Jul 1, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Mar 6, 2025

Study contacts

Randolph HL Wong, FRCS
principal investigator · Chinese University of Hong Kong

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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