- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03265041
Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography)
August 2, 2021 updated by: Eman Abdallah Hasaballah Farag, Assiut University
Predictors of Long Term Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography)
To detect and evaluate the predictors of graft patency after coronary artery bypass graft surgery as assessed by multi-slice CT coronary angiography validated by coronary angiography
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Coronary artery bypass grafting (CABG) is an effective treatment of complex, multi-vessel coronary artery disease(1) .The majority of these patients receive left internal mammary artery (IMA) grafts to the left anterior descending (LAD) coronary artery and saphenous vein grafts (SVGs) or other conduits to the remaining vessels.
Based on small studies of selected groups of patients, it is generally believed that SVGs have a 40% to 50% 10-year patency and that the LIMA has a 90% to 95% 10-year patency The success of coronary artery bypass grafting (CABG) is dependent on the long-term patency of the arterial and venous grafts.(2)
Graft failure is a surrogate marker for future cardiac events, including repeat revascularization, myocardial infarction ,and death(3)(4).
Vein graft occlusion in the perioperative period is due to thrombosis resulting from technical problems.
Vein graft occlusion within the first year is attributed to intimal proliferation, although after 1 year, atherosclerosis is thought to be the dominant factor (5) .
LIMA graft failure was defined as diffuse and >95% conduit narrowing ("string sign" When IMA graft failure occurs, technical error is the most common cause in the early postoperative period, while late (and rare) IMA failure include progressive fibro-intimal proliferation and atherosclerosis either in the IMA graft or in the native LAD vessel)(6) Traditionally, graft patency has been evaluated with coronary angiography (ICA) but, since the advent of multi-detector computed tomography (MDCT), the temptation to use a noninvasive and widely available technique to study coronary artery bypass graft (CABG) patients has been stronger.
The introduction of scanners like 64-slice and 128-slice upwards-along with new scan protocols opens new perspectives in non-invasive assessment of graft patency.(7)
The pooled sensitivity and specificity of detecting complete graft occlusions - according to( Barbero et al ,2016) ,was 99% and 99% respectively as compared to the standard of coronary angiography.
(8) Computed tomographic angiography, labeled as Appropriate test for evaluation of bypass grafts and coronary anatomy (9)
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assiut, Egypt, 71515
- Assiut University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
• All patients underwent coronary artery bypass graft surgery more than one year ago complaining of chest pain presented to Assuit university heart center
Description
Inclusion Criteria:
- All patients underwent coronary artery bypass graft surgery more than one year ago complaining of chest pain are included in the study from September 2017 to September 2018
- Written consent, free and informed
Exclusion Criteria:
• Renal insufficiency (serum creatinine >1.6 mg/dl).
- Contrast hypersensitivity.
- Irregular heart rhythm (e.g. Atrial fibrillation).
- Inability to hold breath for at least 10 seconds
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
detection of predictors of long term graft patency following CABG
Time Frame: 1 year
|
a. Primary (main): evaluation of long term predictors of graft patency following coronary artery bypass graft surgery
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of re-hospitalization rate following CABG
Time Frame: 1 year
|
1 year
|
Relation between type of the graft and graft patency
Time Frame: 1 year
|
1 year
|
Detection of sensitivity and specificity of CT coronary angiography for detection and assessment of graft patency
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Harskamp RE, Alexander JH, Ferguson TB Jr, Hager R, Mack MJ, Englum B, Wojdyla D, Schulte PJ, Kouchoukos NT, de Winter RJ, Gibson CM, Peterson ED, Harrington RA, Smith PK, Lopes RD. Frequency and Predictors of Internal Mammary Artery Graft Failure and Subsequent Clinical Outcomes: Insights From the Project of Ex-vivo Vein Graft Engineering via Transfection (PREVENT) IV Trial. Circulation. 2016 Jan 12;133(2):131-8. doi: 10.1161/CIRCULATIONAHA.115.015549. Epub 2015 Dec 8.
- Di Lazzaro D, Crusco F. CT angio for the evaluation of graft patency. J Thorac Dis. 2017 Apr;9(Suppl 4):S283-S288. doi: 10.21037/jtd.2017.03.111.
- Barbero U, Iannaccone M, d'Ascenzo F, Barbero C, Mohamed A, Annone U, Benedetto S, Celentani D, Gagliardi M, Moretti C, Gaita F. 64 slice-coronary computed tomography sensitivity and specificity in the evaluation of coronary artery bypass graft stenosis: A meta-analysis. Int J Cardiol. 2016 Aug 1;216:52-7. doi: 10.1016/j.ijcard.2016.04.156. Epub 2016 Apr 22.
- TTE/TEE Appropriateness Criteria Writing Group; Douglas PS, Khandheria B, Stainback RF, Weissman NJ; TTE/TEE Appropriateness Criteria Technical Panel; Brindis RG, Patel MR, Alpert JS, Fitzgerald D, Heidenreich P, Martin ET, Messer JV, Miller AB, Picard MH, Raggi P, Reed KD, Rumsfeld JS, Steimle AE, Tonkovic R, Vijayaraghavan K, Yeon SB; ACCF Appropriateness Criteria Working Group; Hendel RC, Peterson E, Wolk MJ, Allen JM; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American Society of Echocardiography; American College of Emergency Physicians; American Society of Nuclear Cardiology; Society for Cardiovascular Angiography and Interventions; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance. ACCF/ASE/ACEP/ASNC/SCAI/SCCT/SCMR 2007 appropriateness criteria for transthoracic and transesophageal echocardiography: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American Society of Echocardiography, American College of Emergency Physicians, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and the Society for Cardiovascular Magnetic Resonance. Endorsed by the American College of Chest Physicians and the Society of Critical Care Medicine. J Am Soc Echocardiogr. 2007 Jul;20(7):787-805. doi: 10.1016/j.echo.2007.06.011. No abstract available.
- Goldman S, Zadina K, Krasnicka B, Moritz T, Sethi G, Copeland J, Ovitt T, Henderson W. Predictors of graft patency 3 years after coronary artery bypass graft surgery. Department of Veterans Affairs Cooperative Study Group No. 297. J Am Coll Cardiol. 1997 Jun;29(7):1563-8. doi: 10.1016/s0735-1097(97)82539-9.
- Greenland P, Knoll MD, Stamler J, Neaton JD, Dyer AR, Garside DB, Wilson PW. Major risk factors as antecedents of fatal and nonfatal coronary heart disease events. JAMA. 2003 Aug 20;290(7):891-7. doi: 10.1001/jama.290.7.891.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
December 31, 2020
Study Registration Dates
First Submitted
August 25, 2017
First Submitted That Met QC Criteria
August 25, 2017
First Posted (Actual)
August 29, 2017
Study Record Updates
Last Update Posted (Actual)
August 9, 2021
Last Update Submitted That Met QC Criteria
August 2, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT coronary post CABG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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