Ischemia and Inflammatory Markers Among Patients With Coronary Artery Ectasia

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05692115
Collaborator
(none)
90
36

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: stress ECG

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
90 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Ischemia and Inflammatory Markers Among Patients With Coronary Artery Ectasia
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
case

Coronary Artery Ectasia patients

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

control

Normal coronary artery patients

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

Outcome Measures

Primary Outcome Measures

  1. Ischemia and Inflammatory markers among patients with coronary artery ectasia . [2 years]

    Incidence of exercise induced ischemic changes on stress ECG: ST-T changes and chest pain reported by patient.

Secondary Outcome Measures

  1. Ischemia and Inflammatory markers among patients with coronary artery ectasia . [2 years]

    Assays of inflammatory markers measured at a fixed time interval among patients as: NLR, RDW, hs-CRP, IL6.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Kerolos Nageh Nanoush Hakeem, Resident, Assiut University
ClinicalTrials.gov Identifier:
NCT05692115
Other Study ID Numbers:
  • Stress ECG,inflammation in CAE
First Posted:
Jan 20, 2023
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Kerolos Nageh Nanoush Hakeem, Resident, Assiut University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2023