Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06220682
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2023-12-27
Brief Title:
Endothelial NO Synthase Polymorphic Gene in Coronary Artery Dilation Disease
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Role of Endothelial Nitric Oxide Synthase Polymorphic Gene c894 GT in Coronary Artery Dilation Disease
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Introduction The coronary artery dilatations disease Coronary artery aneurysmcoronary artery ectasia characterized by inappropriate coronary artery dilations c894GT 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 c894GT 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 c894GT gene polymorphism and angiographically dilated coronary artery CAACAE 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 CAACAE 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
Aim of study To study correlation between the c894GT gene polymorphism and angiographically dilated coronary artery CAACAE 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 CAACAE 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
Detailed Description:
Aim of Work We aim at determining the potential correlations between polymorphism of nitric oxide gene c894GT 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 CAACAE 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 13 of length of CA where its diameter is 15 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 13 of the length of the CA also with diameter 15 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 125L TaqMan Genotyping Master Mix 2x - 125 µL TaqMan genotyping assay20x -50µL genomic DNA- 625µL DNase-free RNasefree water is used to perform PCR
Primary outcome To study correlation between the c894GT gene polymorphism and angiographically dilated coronary artery CAACAE Secondary outcome To determine whether there is any association between this polymorphism and atherosclerotic CAD
Statistical analysis SPSS v21 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 005
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 CAACAE 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 13 of length of CA where its diameter is 15 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 13 of the length of the CA also with diameter 15 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 125L TaqMan Genotyping Master Mix 2x - 125 µL TaqMan genotyping assay20x -50µL genomic DNA- 625µL DNase-free RNasefree water is used to perform PCR
Primary outcome To study correlation between the c894GT gene polymorphism and angiographically dilated coronary artery CAACAE Secondary outcome To determine whether there is any association between this polymorphism and atherosclerotic CAD
Statistical analysis SPSS v21 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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None