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

Coronary Artery Disease Clinical Trial

Official title:

Impact of Cholesterol Level on Long-term Angiographic Outcome of Coronary Artery Bypass Grafting

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05393882
• Other study ID #: CRE Ref no. 2022.134
• Status: Not yet recruiting
• Start date: September 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: July 2023
• Source: Chinese University of Hong Kong
• Contact: Randolph HL Wong, FRCS
• Phone: 35052629
• Email: wonhl1[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bypass Graft Occlusion
• Bypass Graft Stenosis
• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Bypass Graft Stenosis
• Coronary Stenosis
• Dyslipidemias
• Hypercholesterolemia
• Hyperlipidemia
• Hyperlipidemias

Intervention

Radiation:
• Computed 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

References & Publications (6)

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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft patency	Graft patency as assessed by computed tomographic coronary angiogram, using Fitzgibbon classification	Immediately after CTCA
Secondary	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	Immediately after CTCA