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Genetics Study of In-stent Restenosis (ISR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01670396
Recruitment Status : Unknown
Verified August 2012 by Shanghai Zhongshan Hospital.
Recruitment status was:  Recruiting
First Posted : August 22, 2012
Last Update Posted : August 22, 2012
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief 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).

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: G Protein β3 Subunit (GNB3) Polymorphism and Restenosis of Coronary Drug-eluting Stents
Study Start Date : March 2012
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : September 2012

in-stent restenosis
non-in-stent restenosis

Primary Outcome Measures :
  1. In-stent restenosis [ Time Frame: 6-24months after stent implanting ]

Secondary Outcome Measures :
  1. target lesion revascularization (TLR) [ Time Frame: 6-24months after stent implanting ]
  2. re-myocardial infarction [ Time Frame: 6-24months after stent implating ]

Biospecimen Retention:   Samples With DNA
whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hospitalized patients

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01670396

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Contact: Yamei Xu 8613917133371

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Zhongshan Hospital Recruiting
Shanghai, China
Contact: Yamei Xu    8613917133371   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
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Responsible Party: Shanghai Zhongshan Hospital Identifier: NCT01670396    
Other Study ID Numbers: ZS-XN-ISR
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012
Keywords provided by Shanghai Zhongshan Hospital:
coronary stent implant
G protein
drug-eluting stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases