Genetics Study of In-stent Restenosis (ISR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Shanghai Zhongshan Hospital
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT01670396
First received: August 15, 2012
Last updated: August 19, 2012
Last verified: August 2012

August 15, 2012
August 19, 2012
March 2012
August 2012   (final data collection date for primary outcome measure)
In-stent restenosis [ Time Frame: 6-24months after stent implanting ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01670396 on ClinicalTrials.gov Archive Site
  • target lesion revascularization (TLR) [ Time Frame: 6-24months after stent implanting ] [ Designated as safety issue: Yes ]
  • re-myocardial infarction [ Time Frame: 6-24months after stent implating ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Genetics Study of In-stent Restenosis
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).

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.

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood

Probability Sample

Hospitalized patients

Coronary Artery Disease
Not Provided
  • in-stent restenosis
  • non-in-stent restenosis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
September 2012
August 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Yamei Xu 8613917133371 xu.yamei@zs-hospital.sh.cn
China
 
NCT01670396
ZS-XN-ISR
Yes
Shanghai Zhongshan Hospital
Shanghai Zhongshan Hospital
Not Provided
Not Provided
Shanghai Zhongshan Hospital
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP