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NCT01670396 Clinical Trial

Genetics Study of In-stent Restenosis

Coronary Artery Disease Clinical Trial

— ISR  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01670396
Other study ID # ZS-XN-ISR
Secondary ID
Status Recruiting
Phase N/A
First received August 15, 2012
Last updated August 19, 2012
Start date March 2012
Est. completion date September 2012

Study information
Verified date August 2012
Source Shanghai Zhongshan Hospital
Contact Yamei Xu
Phone 8613917133371
Email xu.yamei@zs-hospital.sh.cn
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date September 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Zhongshan Hospital Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary In-stent restenosis 6-24months after stent implanting Yes
Secondary target lesion revascularization (TLR) 6-24months after stent implanting Yes
Secondary re-myocardial infarction 6-24months after stent implating Yes
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