Angiotensin Converting Enzyme rs (1799752) Gene Polymorphism and Development of In-Stent Restenosis in Patients With Stable Coronary Artery DiseasesNCT06055673
Angiotensin Converting Enzyme rs (1799752) Gene Polymorphism and Development of In-Stent Restenosis in Patients With Stable Coronary Artery Diseases in Sohag Hospital University.
An observational study of Angiotensin Converting Enzyme rs (1799752) Gene Polymorphism and Development of In-Stent Restenosis in Patients With Stable Coronary Artery Diseases, run by Sohag University at 1 site in Egypt.
Trial summary
One of the most common medical approaches to the treatment of coronary artery disease (CAD) is the percutaneous coronary intervention (PCI) which became frequent due to high efficiency and safety of this procedure. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Angiotensin Converting Enzyme rs (1799752) Gene Polymorphism and Development of In-Stent Restenosis in Patients With Stable Coronary Artery Diseases
- What is being tested?
- DNA extraction AND Real- time polymerase chain reaction analysis to POLYMORPHISM OF in in-stent restenosis (ISR) in CAD
- How many people
- 182 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2023to 1 Dec 2023
- 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 20 to 70 years
- All sexes
- Adult, Older adult
Study population: This cross-sectional study will include all patients with stable CAD who had previously undergone balloon angioplasty with stenting using drug-eluting stents that referred to the catheterization lab unit of Sohag University for recurrence of angina symptoms or positive cardiac tests. According to the results of the control angiography, the patients will be divided into two groups: patients with ISR confirmed by coronary angiography (angiographic restenosis of more than 50% of the target vessel) and patients without restenosis non ISR group. The patients with ISR were classified into subgroups by the terms of the restenosis development ( early before 12 months \& late after 12 months).
Who may be able to join
- patients with CAD
Who cannot join
- PATIENTS WITHOUT OTHER HEALTH PROBLEMS
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university Hospital
Sohag, Sohag
Magdy M Amin, professor, PORTAL@MED.SOHAG.EDU.EG
About this study
One of the most common medical approaches to the treatment of coronary artery disease (CAD) is the percutaneous coronary intervention (PCI) which became frequent due to high efficiency and safety of this procedure. Modern-day advances in pharmacotherapy and the device innovations over the last thirty years enhanced the benign outcomes of patients with unstable or multivessel CAD, and multiple co-morbidities, treated by PCI .
In-stent restenosis (ISR) is a recognized complication following percutaneous coronary intervention in which the luminal diameter is narrowed through neointimal hyperplasia and vessel remodeling. Although rates of ISR have decreased in most recent years owing to newer generation drug-eluting stents, thinner struts, and better intravascular imaging modalities, ISR remains a prevalent dilemma that proves to be challenging to manage. Several factors have been proposed to contribute to ISR formation, including mechanical stent characteristics, technical factors during the coronary intervention, and biological aspects of drug-eluting stents .identification of risk factors and mechanisms underlying ISR is necessary for understanding the process, the risk stratification, and optimal treatment development. Restenosis, as a physiological response to mechanical damage, involves two mechanisms which are neointimal hyperplasia and vessel remodeling [3]. Several factors such as age, diabetes mellitus, hypertension, stenting of small coronary arteries, and final total length of stents have been shown to be associated with an elevated risk of restenosis.
- Being tested
- DNA extraction AND Real- time polymerase chain reaction analysis to POLYMORPHISM OF in in-stent restenosis (ISR) in CAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA extraction AND Real- time polymerase chain reaction analysis to POLYMORPHISM OF in in-stent restenosis (ISR) in CADGenetic
Also called genotyping of angiotensin converting enzyme in in-stent restenosis
Real- time polymerase chain reaction a gene polymorphism in in-stent restenosis (ISR) in CAD.
| Study group | Role | What they receive |
|---|---|---|
| cases group | patients with ISR confirmed by coronary angiography Receives: Genetic: DNA extraction AND Real- time polymerase chain reaction analysis to POLYMORPHISM OF in in-stent restenosis (ISR) in CAD | |
| patients without restenosis non ISR group | Not described Receives: Genetic: DNA extraction AND Real- time polymerase chain reaction analysis to POLYMORPHISM OF in in-stent restenosis (ISR) in CAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiotensin Converting Enzyme rs (1799752) gene polymorphism and Development of In-Stent Restenosis in Patients with Stable Coronary Artery Diseases
GENOTYPING of Converting Enzyme rs (1799752) gene in Development of In-Stent Restenosis in Patients with Stable Coronary Artery Diseases
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Angiotensin Converting Enzyme rs (1799752) Gene Polymorphism and Development of In-Stent Restenosis in Patients With Stable Coronary Artery DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag 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 crossover
- Time perspective
- Prospective
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zainab Mahmoud Kadry, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06055673
- Sponsor's protocol ID
- Soh-Med-23-09-9PD
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Byrne RA, Joner M, Kastrati A. Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Gruntzig Lecture ESC 2014. Eur Heart J. 2015 Dec 14;36(47):3320-31. doi: 10.1093/eurheartj/ehv511. Epub 2015 Sep 28.
PubMed 26417060Donisan T, Madanat L, Balanescu DV, Mertens A, Dixon S. Drug-Eluting Stent Restenosis: Modern Approach to a Classic Challenge. Curr Cardiol Rev. 2023;19(3):e030123212355. doi: 10.2174/1573403X19666230103154638.
PubMed 36597603Nakano M, Vorpahl M, Otsuka F, Taniwaki M, Yazdani SK, Finn AV, Ladich ER, Kolodgie FD, Virmani R. Ex vivo assessment of vascular response to coronary stents by optical frequency domain imaging. JACC Cardiovasc Imaging. 2012 Jan;5(1):71-82. doi: 10.1016/j.jcmg.2011.09.015.
PubMed 22239896Danilczyk U, Penninger JM. Angiotensin-converting enzyme II in the heart and the kidney. Circ Res. 2006 Mar 3;98(4):463-71. doi: 10.1161/01.RES.0000205761.22353.5f.
PubMed 16514079
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin Converting Enzyme rs (1799752) Gene Polymorphism and Development of In-Stent Restenosis in Patients With Stable Coronary Artery Diseases in Sohag Hospital University.
- ClinicalTrials.gov ID
- NCT06055673
- Acronym / sponsor ID
- Soh-Med-23-09-9PD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 Sep 2023 (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.
One of the most common medical approaches to the treatment of coronary artery disease (CAD) is the percutaneous coronary intervention (PCI) which became frequent due to high efficiency and safety of this procedure. Modern-day advances in pharmacotherapy and the device innovations over the last thirty years enhanced the benign outcomes of patients with unstable or multivessel CAD, and multiple co-morbidities, treated by PCI .
In-stent restenosis (ISR) is a recognized complication following percutaneous coronary intervention in which the luminal diameter is narrowed through neointimal hyperplasia and vessel remodeling. Although rates of ISR have decreased in most recent years owing to newer generation drug-eluting stents, thinner struts, and better intravascular imaging modalities, ISR remains a prevalent dilemma that proves to be challenging to manage. Several factors have been proposed to contribute to ISR formation, including mechanical stent characteristics, technical factors during the coronary intervention, and biological aspects of drug-eluting stents .identification of risk factors and mechanisms underlying ISR is necessary for understanding the process, the risk stratification, and optimal treatment development. Restenosis, as a physiological response to mechanical damage, involves two mechanisms which are neointimal hyperplasia and vessel remodeling [3]. Several factors such as age, diabetes mellitus, hypertension, stenting of small coronary arteries, and final total length of stents have been shown to be associated with an elevated risk of restenosis.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases group | – | Genetic: DNA extraction AND Real- time polymerase chain reaction analysis to POLYMORPHISM OF in in-stent restenosis (ISR) in CADpatients with ISR confirmed by coronary angiography |
| patients without restenosis non ISR group | – | Genetic: DNA extraction AND Real- time polymerase chain reaction analysis to POLYMORPHISM OF in in-stent restenosis (ISR) in CAD |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This cross-sectional study will include all patients with stable CAD who had previously undergone balloon angioplasty with stenting using drug-eluting stents that referred to the catheterization lab unit of Sohag University for recurrence of angina symptoms or positive cardiac tests. According to the results of the control angiography, the patients will be divided into two groups: patients with ISR confirmed by coronary angiography (angiographic restenosis of more than 50% of the target vessel) and patients without restenosis non ISR group. The patients with ISR were classified into subgroups by the terms of the restenosis development ( early before 12 months \& late after 12 months).
Key inclusion criteria (1 listed)
- patients with CAD
Key exclusion criteria (1 listed)
- PATIENTS WITHOUT OTHER HEALTH PROBLEMS
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 |
|---|---|---|
| DNA extraction AND Real- time polymerase chain reaction analysis to POLYMORPHISM OF in in-stent restenosis (ISR) in CADAlso: genotyping of angiotensin converting enzyme in in-stent restenosisReal- time polymerase chain reaction a gene polymorphism in in-stent restenosis (ISR) in CAD. | Genetic | cases group, patients without restenosis non ISR group |
Primary outcome
Angiotensin Converting Enzyme rs (1799752) gene polymorphism and Development of In-Stent Restenosis in Patients with Stable Coronary Artery Diseases
Time frame: 2 months
GENOTYPING of Converting Enzyme rs (1799752) gene in Development of In-Stent Restenosis in Patients with Stable Coronary Artery Diseases
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 26417060Byrne RA, Joner M, Kastrati A. Stent thrombosis and restenosis: what have we learned and where are we going? The Andreas Gruntzig Lecture ESC 2014. Eur Heart J. 2015 Dec 14;36(47):3320-31. doi: 10.1093/eurheartj/ehv511. Epub 2015 Sep 28.
- Background: PubMed 36597603Donisan T, Madanat L, Balanescu DV, Mertens A, Dixon S. Drug-Eluting Stent Restenosis: Modern Approach to a Classic Challenge. Curr Cardiol Rev. 2023;19(3):e030123212355. doi: 10.2174/1573403X19666230103154638.
- Background: PubMed 22239896Nakano M, Vorpahl M, Otsuka F, Taniwaki M, Yazdani SK, Finn AV, Ladich ER, Kolodgie FD, Virmani R. Ex vivo assessment of vascular response to coronary stents by optical frequency domain imaging. JACC Cardiovasc Imaging. 2012 Jan;5(1):71-82. doi: 10.1016/j.jcmg.2011.09.015.
- Background: PubMed 16514079Danilczyk U, Penninger JM. Angiotensin-converting enzyme II in the heart and the kidney. Circ Res. 2006 Mar 3;98(4):463-71. doi: 10.1161/01.RES.0000205761.22353.5f.
- Individual participant dataSharing planned: No
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.
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 Angiotensin Converting Enzyme rs (1799752) Gene Polymorphism and Development of In-Stent Restenosis in Patients With Stable Coronary Artery Diseases, run by Sohag 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 1 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zeinab M Kadry, lecturer (01225960747, zainbmahmoud@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angiotensin Converting Enzyme rs (1799752) gene polymorphism and Development of In-Stent Restenosis in Patients with Stable Coronary Artery Diseases (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06055673, which also lists 4 linked publications.
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 28 Sep 2023.