Angiotensin Converting Enzyme rs (1799752) Gene Polymorphism and Development of In-Stent Restenosis in Patients With Stable Coronary Artery Diseases in Sohag Hospital University.

September 20, 2023 updated by: Zainab Mahmoud Kadry, Sohag University

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

182

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

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).

Description

Inclusion Criteria:

  • patients with CAD

Exclusion Criteria:

  • PATIENTS WITHOUT OTHER HEALTH PROBLEMS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cases group
patients with ISR confirmed by coronary angiography
Genetic: DNA extraction AND Real- time polymerase chain reaction analysis to POLYMORPHISM OF in in-stent restenosis (ISR) in CAD
Real- time polymerase chain reaction a gene polymorphism in in-stent restenosis (ISR) in CAD.
Other Names:
  • genotyping of angiotensin converting enzyme in in-stent restenosis
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
Real- time polymerase chain reaction a gene polymorphism in in-stent restenosis (ISR) in CAD.
Other Names:
  • genotyping of angiotensin converting enzyme in in-stent restenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-23-09-9PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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