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Genetics Study of In-stent Restenosis (ISR)

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Study Description
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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.

Study Design
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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
Groups and Cohorts
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Group/Cohort
in-stent restenosis
non-in-stent restenosis


Outcome Measures
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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

Eligibility Criteria
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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
Criteria

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.
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01670396


Contacts
Contact: Yamei Xu 8613917133371 xu.yamei@zs-hospital.sh.cn

Locations
China
Zhongshan Hospital Recruiting
Shanghai, China
Contact: Yamei Xu    8613917133371    xu.yamei@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
More Information
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01670396     History of Changes
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
polymorphism
G protein
drug-eluting stent
restenosis

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases