Ischemia and Inflammatory Markers Among Patients With Coronary Artery Ectasia

July 26, 2026 updated by: Kerolos Nageh Nanoush Hakim, Assiut University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

cases : Coronary Artery Ectasia patients controls : Normal coronary artery patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Ischemia and Inflammatory markers among patients with coronary artery ectasia .
Time Frame: 2 years
Assays of inflammatory markers measured at a fixed time interval among patients as: NLR, RDW, hs-CRP, IL6.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Stress ECG,inflammation in CAE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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