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AzTrials

Coronary Artery DiseaseNCT03265041

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

An observational study of Coronary Artery Disease, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
multi-slice CT coronary angiography and coronary angiography
How many people
40 participants
Where
1 siteEgypt
Study dates
1 Sep 2018to 31 Dec 2020
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 40 to 80 years
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut university

    Asyut, 71515

Other trials in Egypt

About this study

Official title: 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

Read the 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)

Being tested
multi-slice CT coronary angiography and coronary angiography
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multi-slice CT coronary angiography and coronary angiographyDiagnostic test

    multi-slice CT coronary angiography to evaluate graft number and patency validated by coronary angiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. detection of predictors of long term graft patency following CABG

    1. Primary (main): evaluation of long term predictors of graft patency following coronary artery bypass graft surgery
    2. 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 .
    3. Biochemical risk factors e.g HDL, LDL, Total cholesterol level
    4. Angiographic risk factors : competitive flow and degree of stenosis in the native vessels.

    Measured: 1 year

Secondary outcomes (3)

  1. Assessment of re-hospitalization rate following CABG

    Measured: 1 year

  2. Relation between type of the graft and graft patency

    Measured: 1 year

  3. Detection of sensitivity and specificity of CT coronary angiography for detection and assessment of graft patency

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Aug 2017
  2. Study start1 Sep 2018
  3. Primary completion30 Sep 2020
  4. Study completion31 Dec 2020

Resources

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
Other
Time perspective
Retrospective
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03265041
Sponsor's protocol ID
CT coronary post CABG
Status last verified
Aug 2021
First submitted
25 Aug 2017
Last updated
9 Aug 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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

  • 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.

    PubMed 28540071

  • 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.

    PubMed 27140337

  • 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.

    PubMed 17617305

  • 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.

    PubMed 9180120

  • 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.

    PubMed 12928465

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Assiut University at 1 site in Egypt.

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 2 inclusion and 4 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: finished, as of the sponsor's last update on 9 Aug 2021. 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

detection of predictors of long term graft patency following CABG (time frame: 1 year). 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 NCT03265041, 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 9 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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