Clinical trial NCT05393882: Impact of Cholesterol Level on Long-term Coronary Bypass Graft Patency
Official title: Impact of Cholesterol Level on Long-term Angiographic Outcome of Coronary Artery Bypass Grafting
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Coronary Artery Disease
Bypass Graft Stenosis
Dyslipidemias
Bypass Graft Occlusion
Coronary Bypass Graft Stenosis
Coronary Artery Stenosis
Hyperlipidemia
Hypercholesterolemia
Keywords: Bypass graft failure
Dyslipidemia
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Graft patency
timeFrame: Immediately after CTCA
Secondary outcomes:
measure: Actuarial cardiac events
timeFrame: Immediately after CTCA
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Chinese University of Hong Kong
name: Randolph HL Wong, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.