NCT01670396

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2012

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

August 22, 2012

Status Verified

August 1, 2012

Enrollment Period

5 months

First QC Date

August 15, 2012

Last Update Submit

August 19, 2012

Conditions

Coronary Artery Disease

Keywords

coronary stent implantpolymorphismG proteindrug-eluting stentrestenosis

Outcome Measures

Primary Outcomes (1)

  • In-stent restenosis

    6-24months after stent implanting

Secondary Outcomes (2)

  • target lesion revascularization (TLR)

    6-24months after stent implanting

  • re-myocardial infarction

    6-24months after stent implating

Study Arms (2)

in-stent restenosis

non-in-stent restenosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Hospitalized patients

You may qualify if:

  • Patients who underwent follow-up angiography. All the patients must had been implanted with DES during the last two years.

You may not qualify if:

  • For the non-ISR group, the patients underwent follow-up angiography less than 6 months away from stent implanting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Yamei Xu

CONTACT

8613917133371xu.yamei@zs-hospital.sh.cn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 22, 2012

Study Start

March 1, 2012

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

August 22, 2012

Record last verified: 2012-08

Locations

CN(1)