Genetics Study of In-stent Restenosis (ISR)

This study is currently recruiting participants.
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
  Purpose

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
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: G Protein β3 Subunit (GNB3) Polymorphism and Restenosis of Coronary Drug-eluting Stents

Resource links provided by NLM:


Further study details as provided by Shanghai Zhongshan Hospital:

Primary Outcome Measures:
  • In-stent restenosis [ Time Frame: 6-24months after stent implanting ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

whole blood


Estimated Enrollment: 300
Study Start Date: March 2012
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
in-stent restenosis
non-in-stent restenosis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT01670396     History of Changes
Other Study ID Numbers: ZS-XN-ISR
Study First Received: August 15, 2012
Last Updated: August 19, 2012
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014