Coronary Artery DiseaseISRNCT01670396
Genetics Study of In-stent Restenosis
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Sep 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients
Who may be able to join
- Patients who underwent follow-up angiography. All the patients must had been implanted with DES during the last two years.
Who cannot join
- For the non-ISR group, the patients underwent follow-up angiography less than 6 months away from stent implanting.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital
Shanghai
Yamei Xu, 8613917133371, xu.yamei@zs-hospital.sh.cn
About this study
Official title: 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).
Read the 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.
- Conditions
- Coronary Artery Disease
- Keywords
- coronary stent implant, polymorphism, G protein, drug-eluting stent, restenosis
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| in-stent restenosis | Not described | |
| non-in-stent restenosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-stent restenosis
Measured: 6-24months after stent implanting
Secondary outcomes (2)
target lesion revascularization (TLR)
Measured: 6-24months after stent implanting
re-myocardial infarction
Measured: 6-24months after stent implating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionAug 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670396
- Sponsor's protocol ID
- ZS-XN-ISR
- Acronym
- ISR
- Status last verified
- Aug 2012
- First submitted
- 15 Aug 2012
- Last updated
- 22 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- G Protein β3 Subunit (GNB3) Polymorphism and Restenosis of Coronary Drug-eluting Stents
- ClinicalTrials.gov ID
- NCT01670396
- Acronym / sponsor ID
- ISR / ZS-XN-ISR
- Conditions
- Coronary Artery Disease
- Keywords
- coronary stent implant, polymorphism, G protein, drug-eluting stent, restenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 22 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in-stent restenosis | – | – |
| non-in-stent restenosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients
Key inclusion criteria (1 listed)
- Patients who underwent follow-up angiography. All the patients must had been implanted with DES during the last two years.
Key exclusion criteria (1 listed)
- For the non-ISR group, the patients underwent follow-up angiography less than 6 months away from stent implanting.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-stent restenosis
Time frame: 6-24months after stent implanting
2 secondary outcomes
target lesion revascularization (TLR)
Time frame: 6-24months after stent implanting
re-myocardial infarction
Time frame: 6-24months after stent implating
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yamei Xu (8613917133371, xu.yamei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-stent restenosis (time frame: 6-24months after stent implanting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2012.