Coronary Artery DiseaseNCT05393882
Impact of Cholesterol Level on Long-term Coronary Bypass Graft Patency
An observational study of Coronary Artery Disease and Bypass Graft Stenosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Bypass Graft Stenosis, Dyslipidemias
- What is being tested?
- Computed tomography coronary angiogram
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2025to 31 Dec 2027
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All consecutive patients on record who underwent coronary artery bypass graft surgery in 2007 and 2008
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Cholesterol Level on Long-term Angiographic Outcome of Coronary Artery Bypass Grafting
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.
- Conditions
- Coronary Artery Disease, Bypass Graft Stenosis, Dyslipidemias, Bypass Graft Occlusion, Coronary Bypass Graft Stenosis, Coronary Artery Stenosis
- Being tested
- Computed tomography coronary angiogram
- Keywords
- Bypass graft failure, Dyslipidemia
- Medical subject headings
- Coronary Artery Disease, Dyslipidemias, Coronary Stenosis, Hyperlipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed tomography coronary angiogramRadiation
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft patency
Graft patency as assessed by computed tomographic coronary angiogram, using Fitzgibbon classification
Measured: 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
Measured: Immediately after CTCA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study startSep 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randolph Wong, Chinese University of Hong Kong
- Investigators
- Randolph HL Wong, FRCS, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393882
- Sponsor's protocol ID
- CRE Ref no. 2022.134
- Status last verified
- Aug 2024
- First submitted
- 20 May 2022
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 18852363Knatterud 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 10889125Li 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 35174230Niclauss 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 27298393Farooq 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 23537954Karolyi 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cholesterol Level on Long-term Angiographic Outcome of Coronary Artery Bypass Grafting
- ClinicalTrials.gov ID
- NCT05393882
- Acronym / sponsor ID
- CRE Ref no. 2022.134
- Conditions
- Coronary Artery Disease, Bypass Graft Stenosis, Dyslipidemias, Bypass Graft Occlusion, Coronary Bypass Graft Stenosis, Coronary Artery Stenosis
- Keywords
- Bypass graft failure, Dyslipidemia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All consecutive patients on record who underwent coronary artery bypass graft surgery in 2007 and 2008
Key exclusion criteria (8 listed)
- Death
- Single vessel LIMA-LAD anastomosis only
- Concomitant valve and aortic procedures
- Concomitant repair of post-infarct ventricular septal rupture
- Defaulted follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed tomography coronary angiogramPreparation * 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 | Radiation | – |
Primary outcome
Graft patency
Time frame: Immediately after CTCA
Graft patency as assessed by computed tomographic coronary angiogram, using Fitzgibbon classification
1 secondary outcome
Actuarial cardiac events
Time frame: Immediately after CTCA
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Background: PubMed 18852363Kulik 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.
- Background: PubMed 10889125Knatterud 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.
- Background: PubMed 35174230Li 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.
- Background: PubMed 27298393Niclauss 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.
- Background: PubMed 23537954Farooq 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.
- Background: PubMed 34410332Karolyi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randolph HL Wong, FRCS principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Bypass Graft Stenosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft patency (time frame: Immediately after CTCA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05393882, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.