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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

Tracking Information
First Submitted Date August 15, 2012
First Posted Date August 22, 2012
Last Update Posted Date August 22, 2012
Study Start Date March 2012
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 19, 2012)
In-stent restenosis [ Time Frame: 6-24months after stent implanting ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: August 19, 2012)
  • target lesion revascularization (TLR) [ Time Frame: 6-24months after stent implanting ]
  • re-myocardial infarction [ Time Frame: 6-24months after stent implating ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetics Study of In-stent Restenosis
Official Title G Protein β3 Subunit (GNB3) Polymorphism and Restenosis of Coronary Drug-eluting Stents
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).
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
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood
Sampling Method Probability Sample
Study Population Hospitalized patients
Condition Coronary Artery Disease
Intervention Not Provided
Study Groups/Cohorts
  • in-stent restenosis
  • non-in-stent restenosis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: August 19, 2012)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2012
Estimated Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01670396
Other Study ID Numbers ZS-XN-ISR
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Shanghai Zhongshan Hospital
Study Sponsor Shanghai Zhongshan Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Shanghai Zhongshan Hospital
Verification Date August 2012