NCT05692115

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

2 years

First QC Date

January 11, 2023

Last Update Submit

January 11, 2023

Conditions

Coronary Artery Ectasia

Keywords

stress ECG and inflammatory markers in Coronary Artery Ectasia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Ischemia and Inflammatory markers among patients with coronary artery ectasia .

    2 years

Study Arms (2)

case

Coronary Artery Ectasia patients

Diagnostic Test: stress ECG

control

Normal coronary artery patients

Diagnostic Test: stress ECG

Interventions

stress ECGDIAGNOSTIC_TEST

stress ECG to patients suspected to be ischemic patients .

casecontrol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Subjects with suspected CAD who are undergoing elective coronary angiography.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

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

    PMID: 20378518BACKGROUND

  • 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.

    PMID: 22201872BACKGROUND

  • 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.

    PMID: 27218145BACKGROUND

  • 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.

    PMID: 27142049BACKGROUND

  • 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.

    PMID: 24818774BACKGROUND

  • 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.

    PMID: 18694609BACKGROUND

  • 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.

    PMID: 32519552BACKGROUND

  • 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.

    PMID: 25980945BACKGROUND

MeSH Terms

Conditions

Coronary Aneurysm

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesAneurysmVascular Diseases

Central Study Contacts

Kerolos Nageh Nanoush Hakeem, Resident

CONTACT

+201206123237kerolos.nn1996@gmail.com

Tarek Abd El Hameed Nagib, Assistant Professor

CONTACT

+201099975128Tarek.a.n.ahmed@med.aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 20, 2023

Study Start

January 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2026

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share