Genetics Study of In-stent Restenosis (ISR)

August 19, 2012 updated by: Shanghai Zhongshan Hospital

G Protein β3 Subunit (GNB3) Polymorphism and Restenosis of Coronary Drug-eluting Stents

The investigators hypothesized that genetic variants of G protein influence the development of restenosis and clinical outcome of patients receiving drug-eluting stents (DES).

Study Overview

Status

Unknown

Conditions

Coronary Artery Disease

Detailed Description

Although drug-eluting stents (DES) have reduced restenosis rates compared with bare-metal stents, the restenosis rate is still high in the high-risk group. G protein plays important roles in the signal transduction leading to vascular smooth muscle proliferation. The initial and subsequent studies suggest that the T allele of C825T polymorphism is associated with enhanced transmembrane signaling via Gi proteins.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

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

Study Locations

China
- - Shanghai, China
    - Recruiting
    - Zhongshan Hospital
    - Contact:
      
      Yamei Xu
      
      Phone Number: 8613917133371
      
      Email: xu.yamei@zs-hospital.sh.cn

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hospitalized patients

Description

Inclusion Criteria:

Patients who underwent follow-up angiography. All the patients must had been implanted with DES during the last two years.

Exclusion Criteria:

For the non-ISR group, the patients underwent follow-up angiography less than 6 months away from stent implanting.

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
in-stent restenosis
non-in-stent restenosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
In-stent restenosis Time Frame: 6-24months after stent implanting	6-24months after stent implanting

Secondary Outcome Measures

Outcome Measure	Time Frame
target lesion revascularization (TLR) Time Frame: 6-24months after stent implanting	6-24months after stent implanting
re-myocardial infarction Time Frame: 6-24months after stent implating	6-24months after stent implating

Collaborators and Investigators

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

Sponsor

Shanghai Zhongshan Hospital

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

March 1, 2012

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

September 1, 2012

Study Registration Dates

First Submitted

August 15, 2012

First Submitted That Met QC Criteria

August 19, 2012

First Posted (Estimate)

August 22, 2012

Study Record Updates

Last Update Posted (Estimate)