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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05692115
Other study ID # Stress ECG,inflammation in CAE
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2023
Est. completion date January 2026

Study information

Verified date January 2023
Source Assiut University
Contact Kerolos Nageh Nanoush Hakeem, Resident
Phone +201206123237
Email kerolos.nn1996@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

study the ischemic burden in patients with CAE, and its relation to inflammatory markers. - To assess the ischemic response during exercise ECG among patients with different variants of CAE. - To assess inflammatory biomarkers among patient with different variants of CAE - To assess the relation between the ischemic response and inflammatory markers.


Description:

Coronary artery ectasia (CAE) is a dilation of the coronary artery lumen. The term "ectasia" refers to diffuse dilation of a coronary artery, while focal coronary dilation is called a "coronary aneurysm." The definition of coronary artery ectasia is a dilatation exceeding more than one-third of the coronary artery length with the diameter of the dilated segment measuring more than 1.5 times the diameter of a normal adjacent segment. Coronary artery ectasia is well recognized, but uncommon findings encountered during diagnostic coronary angiography. inflammation, platelet activation, endothelial dysfunction, microvascular dysfunction, slow flow and vascular remodeling have all been suggested to play a role . . Available evidence implies that CAE is not a mere variant of CAD; indeed diabetes is negatively associated with CAE and studies pinpoint a critical inflammatory component Turbulent slow flow within dilated coronaries may lead to platelet activation, thrombosis and eventually acute coronary syndrome Local coronary flow disturbances caused by decreased endothelial shear stress has also been proposed as an alternative explanation for the coexistence of CAD and CAE. Intravascular ultrasound (IVUS) evidence suggests that atherosclerotic plaques within ectatic regions of vessels are highly inflamed and meet high-risk plaque criteria Mediators of chronic inflammation, such as growth factors and cellular adhesion models, have been widely described in the pathogenesis of CAE. Specifically, the expression of specific inflammatory markers, particularly IL-6 and CRP, is known to be higher in CAE compared with CAD and healthy controls . Most recently, a large meta-analysis elucidated the role of other contributory markers, neutrophil to lymphocyte ratio (NLR) and red cell distribution width (RDW), in the pathogenesis of CAE Inflammatory markers, C-reactive protein and albumin are believed to be involved in the progression and severity of CAE. Recently, a significantly higher C-reactive protein-to-albumin ratio has been associated with isolated CAE when compared to obstructive CAD and controls. Notably, C-reactive protein-to-albumin ratio also correlated strongly with the severity of CAE, which provides further evidence for its potential role in detection and management We sought to study the ischemic burden in patients with CAE, and its relation to inflammatory markers.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 90
Est. completion date January 2026
Est. primary completion date January 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Subjects with suspected CAD who are undergoing elective coronary angiography. Exclusion Criteria: Patients with a history of cardiomyopathy or myocardial infarction (MI). Patients with recent acute coronary syndrome Patients with severe renal impairment Post CABG patients Patients with physical incapacity

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
stress ECG
stress ECG to patients suspected to be ischemic patients .

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (8)

Aboeata AS, Sontineni SP, Alla VM, Esterbrooks DJ. Coronary artery ectasia: current concepts and interventions. Front Biosci (Elite Ed). 2012 Jan 1;4(1):300-10. doi: 10.2741/377. — View Citation

Antoniadis AP, Chatzizisis YS, Giannoglou GD. Pathogenetic mechanisms of coronary ectasia. Int J Cardiol. 2008 Nov 28;130(3):335-43. doi: 10.1016/j.ijcard.2008.05.071. Epub 2008 Aug 9. — View Citation

Dereli S, Cerik IB, Kaya A, Bektas O. Assessment of the Relationship Between C-Reactive Protein-to-Albumin Ratio and the Presence and Severity of Isolated Coronary Artery Ectasia. Angiology. 2020 Oct;71(9):840-846. doi: 10.1177/0003319720930983. Epub 2020 Jun 10. — View Citation

Devabhaktuni S, Mercedes A, Diep J, Ahsan C. Coronary Artery Ectasia-A Review of Current Literature. Curr Cardiol Rev. 2016;12(4):318-323. doi: 10.2174/1573403x12666160504100159. — View Citation

Eitan A, Roguin A. Coronary artery ectasia: new insights into pathophysiology, diagnosis, and treatment. Coron Artery Dis. 2016 Aug;27(5):420-8. doi: 10.1097/MCA.0000000000000379. — View Citation

Huang QJ, Liu J, Chen MH, Li JJ. Relation of diabetes to coronary artery ectasia: A meta-analysis study. Anadolu Kardiyol Derg. 2014 Jun;14(4):322-7. doi: 10.5152/akd.2014.5327. Epub 2014 May 2. — View Citation

Mavrogeni S. Coronary artery ectasia: from diagnosis to treatment. Hellenic J Cardiol. 2010 Mar-Apr;51(2):158-63. No abstract available. — View Citation

Shao Q, Chen K, Rha SW, Lim HE, Li G, Liu T. Usefulness of Neutrophil/Lymphocyte Ratio as a Predictor of Atrial Fibrillation: A Meta-analysis. Arch Med Res. 2015 Apr;46(3):199-206. doi: 10.1016/j.arcmed.2015.03.011. Epub 2015 May 14. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Ischemia and Inflammatory markers among patients with coronary artery ectasia . Incidence of exercise induced ischemic changes on stress ECG: ST-T changes and chest pain reported by patient. 2 years
Secondary Ischemia and Inflammatory markers among patients with coronary artery ectasia . Assays of inflammatory markers measured at a fixed time interval among patients as: NLR, RDW, hs-CRP, IL6. 2 years
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