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

NCT05393882 | Withdrawn

• 1 other identifier: CRE Ref no. 2022.134
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (1)

• Graft patency

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

  Immediately after CTCA

Secondary Outcomes (1)

• Actuarial cardiac events

  Immediately after CTCA

Interventions

Computed tomography coronary angiogram RADIATION

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Related Publications (6)

• 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.

  PMID: 18852363 BACKGROUND

• 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.

  PMID: 10889125 BACKGROUND

• 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.

  PMID: 35174230 BACKGROUND

• 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.

  PMID: 27298393 BACKGROUND

• 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.

  PMID: 23537954 BACKGROUND

• 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.

  PMID: 34410332 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Dyslipidemias; Coronary Stenosis; Hyperlipidemias; Hypercholesterolemia

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Randolph HL Wong, FRCS

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 15 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Randolph Wong Hung Leung

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 26, 2022
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 6, 2025

Record last verified: 2024-08

Locations

HK (1)