Coronary Artery EctasiaNCT05692115
Ischemia and Inflammatory Markers Among Patients With Coronary Artery Ectasia
An observational study of Coronary Artery Ectasia, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Ectasia
- What is being tested?
- stress ECG
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: cases : Coronary Artery Ectasia patients controls : Normal coronary artery patients
Who may be able to join
- Subjects with suspected CAD who are undergoing elective coronary angiography.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Coronary Artery Ectasia
- Being tested
- stress ECG
- Keywords
- stress ECG and inflammatory markers in Coronary Artery Ectasia
- Medical subject headings
- Coronary Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stress ECGDiagnostic test
stress ECG to patients suspected to be ischemic patients .
| Study group | Role | What they receive |
|---|---|---|
| case | Coronary Artery Ectasia patients Receives: Diagnostic Test: stress ECG | |
| control | Normal coronary artery patients Receives: Diagnostic Test: stress ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study startAug 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery EctasiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolos Nageh Nanoush Hakim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692115
- Sponsor's protocol ID
- Stress ECG,inflammation in CAE
- Status last verified
- Jul 2026
- First submitted
- 11 Jan 2023
- Last updated
- 28 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mavrogeni S. Coronary artery ectasia: from diagnosis to treatment. Hellenic J Cardiol. 2010 Mar-Apr;51(2):158-63. No abstract available.
PubMed 20378518Aboeata 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.
PubMed 22201872Eitan 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.
PubMed 27218145Devabhaktuni 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.
PubMed 27142049Huang 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.
PubMed 24818774Antoniadis 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.
PubMed 18694609Dereli 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.
PubMed 32519552Shao 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.
PubMed 25980945
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemia and Inflammatory Markers Among Patients With Coronary Artery Ectasia
- ClinicalTrials.gov ID
- NCT05692115
- Acronym / sponsor ID
- Stress ECG,inflammation in CAE
- Conditions
- Coronary Artery Ectasia
- Keywords
- stress ECG and inflammatory markers in Coronary Artery Ectasia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case | – | Diagnostic Test: stress ECGCoronary Artery Ectasia patients |
| control | – | Diagnostic Test: stress ECGNormal coronary artery patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- cases : Coronary Artery Ectasia patients controls : Normal coronary artery patients
Key inclusion criteria (1 listed)
- Subjects with suspected CAD who are undergoing elective coronary angiography.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stress ECGstress ECG to patients suspected to be ischemic patients . | Diagnostic test | case, control |
Primary outcome
Ischemia and Inflammatory markers among patients with coronary artery ectasia .
Time frame: 2 years
Incidence of exercise induced ischemic changes on stress ECG: ST-T changes and chest pain reported by patient.
1 secondary outcome
Ischemia and Inflammatory markers among patients with coronary artery ectasia .
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 20378518Mavrogeni S. Coronary artery ectasia: from diagnosis to treatment. Hellenic J Cardiol. 2010 Mar-Apr;51(2):158-63. No abstract available.
- Background: PubMed 22201872Aboeata 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.
- Background: PubMed 27218145Eitan 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.
- Background: PubMed 27142049Devabhaktuni 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.
- Background: PubMed 24818774Huang 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.
- Background: PubMed 18694609Antoniadis 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.
- Background: PubMed 32519552Dereli 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.
- Background: PubMed 25980945Shao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Ectasia, run by Assiut University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kerolos Nageh Nanoush Hakim, Resident (+201206123237, kerolos.nn1996@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemia and Inflammatory markers among patients with coronary artery ectasia . (time frame: 2 years). 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 NCT05692115, which also lists 8 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 28 Jul 2026.