Genetics Study of In-stent Restenosis (ISR)
This study is currently recruiting participants.
Verified August 2012 by Shanghai Zhongshan Hospital
Sponsor:
Shanghai Zhongshan Hospital
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
| Tracking Information | |||||
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| First Received Date ICMJE | August 15, 2012 | ||||
| Last Updated Date | August 19, 2012 | ||||
| Start Date ICMJE | March 2012 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
In-stent restenosis [ Time Frame: 6-24months after stent implanting ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01670396 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Genetics Study of In-stent Restenosis | ||||
| Official Title ICMJE | G Protein β3 Subunit (GNB3) Polymorphism and Restenosis of Coronary Drug-eluting Stents | ||||
| 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). |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: whole blood |
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| Sampling Method | Probability Sample | ||||
| Study Population | Hospitalized patients |
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| Condition ICMJE | Coronary Artery Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Estimated Completion Date | September 2012 | ||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | China | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01670396 | ||||
| Other Study ID Numbers ICMJE | ZS-XN-ISR | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Shanghai Zhongshan Hospital | ||||
| Study Sponsor ICMJE | Shanghai Zhongshan Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | Shanghai Zhongshan Hospital | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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