Coronary Artery EctasiaNCT06220682
Endothelial NO Synthase Polymorphic Gene in Coronary Artery Dilation Disease
An observational study of Coronary Artery Ectasia, run by Cairo University at 1 site in Egypt.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Ectasia
- What is being tested?
- The specific genetic PCR laboratory test were performed for all selected patients for eNOS SNPs
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2020to 30 Jun 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Endothelial Nitric Oxide Synthase Polymorphic Gene (c.894 G>T) in Coronary Artery Dilation Disease
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.
Read the detailed 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).
- Conditions
- Coronary Artery Ectasia
- Being tested
- The specific genetic PCR laboratory test were performed for all selected patients for eNOS SNPs
- Medical subject headings
- Coronary Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The specific genetic PCR laboratory test were performed for all selected patients for eNOS SNPsDiagnostic test
using Real-Time PCR (QuantStudioTM 3 Real-Time PCR) with an allele-specific fluorogenic oligonucleotide probe and a TaqMan pre-designed SNP Genotyping assay
| Study group | Role | What they receive |
|---|---|---|
| normal group | 25 patients angiographically normal coronaries Receives: 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 Receives: Diagnostic Test: The specific genetic PCR laboratory test were performed for all selected patients for eNOS SNPs |
What is being measured
The primary outcome is the main question the study is designed to answer.
: 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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Dec 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery EctasiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Farouk, Cairo University
- Investigators
- Ahmed Mowafy, MD, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220682
- Sponsor's protocol ID
- Kasralainy school of medicine
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Endothelial Nitric Oxide Synthase Polymorphic Gene (c.894 G>T) in Coronary Artery Dilation Disease
- ClinicalTrials.gov ID
- NCT06220682
- Acronym / sponsor ID
- Kasralainy school of medicine
- Conditions
- Coronary Artery Ectasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal group | – | Diagnostic Test: The specific genetic PCR laboratory test were performed for all selected patients for eNOS SNPs25 patients angiographically normal coronaries |
| 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 | – | Diagnostic Test: The specific genetic PCR laboratory test were performed for all selected patients for eNOS SNPs25 patients angiographically had both coronary dilatations and atherosclerotic plaques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The specific genetic PCR laboratory test were performed for all selected patients for eNOS SNPsusing Real-Time PCR (QuantStudioTM 3 Real-Time PCR) with an allele-specific fluorogenic oligonucleotide probe and a TaqMan pre-designed SNP Genotyping assay | Diagnostic test | dilated atherosclerotic group, normal group |
Primary outcome
: To study correlation between the c.894G>T gene polymorphism and angiographically dilated coronary artery (CAA/CAE)
Time frame: 1 year
: To study correlation between the c.894G>T gene polymorphism and angiographically dilated coronary artery (CAA/CAE)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Mowafy, MD study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Ectasia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: To study correlation between the c.894G>T gene polymorphism and angiographically dilated coronary artery (CAA/CAE) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.