Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography)

Coronary Artery Disease Clinical Trial

Official title:

Predictors of Long Term Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03265041
• Other study ID #: CT coronary post CABG
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2020
• Est. primary completion date: September 30, 2020
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Diagnostic Test:
• multi-slice CT coronary angiography and coronary angiography
multi-slice CT coronary angiography to evaluate graft number and patency validated by coronary angiography

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Harskamp RE, Alexander JH, Ferguson TB, Hager R, Mack MJ, Englum B, et al. Frequency and Predictors of Internal Mammary Artery Graft Failure and Subsequent Clinical OutcomesCLINICAL PERSPECTIVE. Circulation [Internet]. 2016;133(2):131-8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/26647082%5Cnhttp://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=PMC4814323%5Cnhttp://circ.ahajournals.org/lookup/doi/10.1161/CIRCULATIONAHA.115.015549

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of predictors of long term graft patency following CABG	a. Primary (main): evaluation of long term predictors of graft patency following coronary artery bypass graft surgery; Clinical risk factors e.g Age, gender, smoking, Diabetus mellitus, hypertension, Dyslipidemia, chronic kidney disease, congestive heart failure, medications especially antiplatelet and statin therapy, beta-blockers and calcium channel blockers .; Biochemical risk factors e.g HDL, LDL, Total cholesterol level; Angiographic risk factors : competitive flow and degree of stenosis in the native vessels.	1 year
Secondary	Assessment of re-hospitalization rate following CABG		1 year
Secondary	Relation between type of the graft and graft patency		1 year
Secondary	Detection of sensitivity and specificity of CT coronary angiography for detection and assessment of graft patency		1 year