NCT06220682

Brief Summary

Introduction: The coronary artery dilatations disease (Coronary artery aneurysm/coronary artery ectasia) characterized by inappropriate coronary artery dilations. (c.894G\>T) is a gene polymorphism that may decreases eNOS enzyme activity which increases the risk for coronary heart disease by affecting released (NO) molecules. One of the most researched variations in eNOS gene is c.894G\>T polymorphism, which changes amino acid sequence at position 298 from Glu (GAG) to Asp (GAT), nevertheless, its role in Coronary dilatations disease still uncertain. Aim of study: To study correlation between the c.894G\>T gene polymorphism and angiographically dilated coronary artery (CAA/CAE), as well as to determine whether there is any association between this polymorphism and atherosclerotic CAD. Methodology: A comparative study on 100 patients with acute coronary syndrome who underwent coronary angiography from December 2020 to June 2022. According to standard angiographic views and expert opinions, patients were divided as, 25 patients normal, 25 patients had only atherosclerotic coronary artery disease, 25 patients had dilated coronaries (CAA/CAE) without atherosclerosis and 25 patients had dilated coronaries with atherosclerotic coronary artery disease. The specific genetic PCR laboratory test were performed for eNOS SNPs (single nucleotide polymorphism) namely, 894G \> T (Glu298Asp; rs 1799983), using Real-Time PCR.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 27, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

December 27, 2023

Last Update Submit

January 24, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • : To study correlation between the c.894G>T gene polymorphism and angiographically dilated coronary artery (CAA/CAE)

    : To study correlation between the c.894G\>T gene polymorphism and angiographically dilated coronary artery (CAA/CAE)

    1 year

Study Arms (4)

normal group

25 patients angiographically normal coronaries

Diagnostic Test: The specific genetic PCR laboratory test were performed for all selected patients for eNOS SNPs

atherosclerotic non dilated group

25 patients angiographically had atherosclerotic plaques with no coronary dilatations

dilated non atherosclerotic group

25 patients angiographically involved coronary dilatations with no atherosclerotic plaques

dilated atherosclerotic group

25 patients angiographically had both coronary dilatations and atherosclerotic plaques

Diagnostic Test: The specific genetic PCR laboratory test were performed for all selected patients for eNOS SNPs

Interventions

using Real-Time PCR (QuantStudioTM 3 Real-Time PCR) with an allele-specific fluorogenic oligonucleotide probe and a TaqMan pre-designed SNP Genotyping assay

dilated atherosclerotic groupnormal group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The total populations in our study were 100 patients, divided into 4 groups depends on angiographic results: Group (1): 25 patients angiographically normal coronaries (normal group). Group (2): 25 patients angiographically had atherosclerotic plaques with no coronary dilatations (atherosclerotic non dilated group). Group (3): 25 patients angiographically involved coronary dilatations with no atherosclerotic plaques (dilated non atherosclerotic group). Group (4): 25 patients angiographically had both coronary dilatations and atherosclerotic plaques (dilated atherosclerotic group).

You may qualify if:

  • Patients who have angiographically coronary artery dilatations (coronary artery aneurysm or ectasia) (CAA/CAE) with or without angiographic evidence of atherosclerotic CAD.
  • Another group of patients with angiographically normal or atherosclerotic coronaries without evidence of dilatation.

You may not qualify if:

  • Patients with secondary coronary dilatations after balloon angioplasty, coronary stent implantation, patients with coronary artery bypass surgery who have post CABG native coronary dilatations, all were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, 11345, Egypt

Location

MeSH Terms

Conditions

Coronary Aneurysm

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesAneurysmVascular Diseases

Study Officials

  • Ahmed Mowafy, MD

    Cairo University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of critical care

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 24, 2024

Study Start

December 1, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations