Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06220682 |
| Other study ID # |
Kasralainy school of medicine |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
January 2024 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
Description:
Aim of Work We aim at determining the potential correlations between polymorphism of nitric
oxide gene (c.894G>T) and angiographically dilated coronary arteries (coronary artery
aneurysm or ectasia), as well as to determine if there is any link to atherosclerotic
coronary diseases (ACAD).
Methodology:
Based on standard coronary angiographic views, two experienced independent operators
evaluated the presence of coronary artery dilatations (CAA, CAE) and associated
atherosclerotic CAD in all patients' angiograms.
Inclusion criteria 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.
Exclusion criteria 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.
Definitions CAE refers to a diffuse dilatation affecting more than 1/3 of length of CA where
its diameter is 1.5 greater than subsequent healthy coronary portion [1, 2, 3].
CAA is less common clinical finding that is described as dilation at the CAs that is < 1/3 of
the length of the CA also with diameter 1.5 greater than normal length of nearby part [1, 2,
3, 4].
Laboratory method and genetic analysis The specific genetic PCR laboratory test were
performed for all selected patients for eNOS SNPs (single nucleotide polymorphism) namely,
894G > T (Glu298Asp; rs 1799983), using Real-Time PCR (QuantStudioTM 3 Real-Time PCR) with an
allele-specific fluorogenic oligonucleotide probe and a TaqMan pre-designed SNP Genotyping
assay (TaqMan technique; Applied Biosystems, Germany), The fluorogenic dyes employed to
achieve allelic discrimination were FAM (6-carboxy-fluorescein) and VIC (Applied Biosystems
proprietary dye). a total reaction volume of 25 L (12.5L TaqMan® Genotyping Master Mix) (2x)
- 1.25 µL TaqMan genotyping assay(20x) -5.0µL genomic DNA- 6.25µL DNase-free, RNasefree
water) is used to perform PCR.
Primary outcome: To study correlation between the c.894G>T gene polymorphism and
angiographically dilated coronary artery (CAA/CAE) Secondary outcome: To determine whether
there is any association between this polymorphism and atherosclerotic CAD.
Statistical analysis SPSS v.21 statistical package was used to code and entering data, where
it described as number and percent for qualitative mean and standard deviation (SD) for
normally distributed data while median and inter quintile rang (IQR) chosen for non-normally
distributed quantitative data.
Comparisons for qualitative variables between groups was mad by chi-square or fissure exact
tests, while comparisons across normally distributed quantitative variables were done using
analysis of variance and post hock 2khs test, and quantitative variables which is not
normally distributed, where compared using (non-parametrical croscal wise and Mann-Whitney u
tests), statistically significant considered when P. values was below or equal (0.05).
