Genetics Study of In-stent Restenosis (ISR)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2012 by Shanghai Zhongshan Hospital.
Recruitment status was Recruiting

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

History of Changes

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

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Coronary Disease Myocardial Ischemia Arterial Occlusive Diseases	Arteriosclerosis Cardiovascular Diseases Heart Diseases Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015

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