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

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT03265041

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Diagnostic Test: multi-slice CT coronary angiography and coronary angiography

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 Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Sep 1, 2018

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Dec 31, 2020

Outcome Measures

Primary Outcome Measures

detection of predictors of long term graft patency following CABG [1 year]
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.

Secondary Outcome Measures

Assessment of re-hospitalization rate following CABG [1 year]
Relation between type of the graft and graft patency [1 year]
Detection of sensitivity and specificity of CT coronary angiography for detection and assessment of graft patency [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut university	Assiut		Egypt	71515

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Eman Abdallah Hasaballah Farag, resident, Assiut University

ClinicalTrials.gov Identifier:

NCT03265041

Other Study ID Numbers:

CT coronary post CABG

First Posted:

Aug 29, 2017

Last Update Posted:

Aug 9, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Aug 9, 2021