- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05393882
Impact of Cholesterol Level on Long-term Coronary Bypass Graft Patency
Impact of Cholesterol Level on Long-term Angiographic Outcome of Coronary Artery Bypass Grafting
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Contacts and Locations
Study Locations
-
-
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Hong Kong, Hong Kong
- Prince of Wales Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Graft patency
Time Frame: Immediately after CTCA
|
Graft patency as assessed by computed tomographic coronary angiogram, using Fitzgibbon classification
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Immediately after CTCA
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Actuarial cardiac events
Time Frame: 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
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Immediately after CTCA
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Randolph HL Wong, FRCS, Chinese University of Hong Kong
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Pathological Conditions, Anatomical
- Heart Diseases
- Metabolic Diseases
- Lipid Metabolism Disorders
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Myocardial Ischemia
- Constriction, Pathologic
- Hypercholesterolemia
- Coronary Artery Disease
- Coronary Stenosis
- Dyslipidemias
- Hyperlipidemias
Other Study ID Numbers
- CRE Ref no. 2022.134
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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