Shanghai Registry of Acute Coronary Events
Recruitment status was Recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | July 7, 2008 | ||||
| Last Updated Date | June 15, 2011 | ||||
| Start Date ICMJE | March 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
major adverse cardiac events(MACE), including death, non-fatal re-MI, and target vessel revascularization [ Time Frame: in-hospital, 30d, and long-term follow-up ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00713557 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
stroke, stent thrombosis [ Time Frame: in-hospital, 30d, and long-term follow-up ] [ Designated as safety issue: Yes ] | ||||
| 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 | Shanghai Registry of Acute Coronary Events | ||||
| Official Title ICMJE | Phase 4 Study to Compare Different Therapeutic Strategies for Patients With ACS | ||||
| Brief Summary | SRACE is an multicenter observational database of outcomes for patients who are hospitalized with an acute coronary events. SRACE includes over 20 hospitals in Shanghai China that have enrolled a total of more than 3,000 patients since 2005, with an annual enrollment of 500 patients. The major purpose of the SRACE program is to evaluate the prognosis of patients admitted to the hospital due to acute coronary events, comparing different therapeutic strategies, in-hospital transferring system, and so on. All participating physicians receive confidential quarterly reports showing ther outcomes side-by-side with the aggregate outcomes of all participating hospitals. |
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| Detailed Description | consecutive patients with STEMI who presented symptoms within 12 hours and treated by primary PCI in Shanghai, were enrolled in the prospective sysytem. Several strategies were applied in these patients, including physician vs. patient transfer strategy, upsteam vs. downstream strategy, Firebird stent vs. Excel stent (bio-absorbable SES), etc. Once the patient was randomized to one of these study, he will be denied to the others. Clinical and angiographic outcomes were compared, with the final purpose to find an optimal strategy in treating AMI patients. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | patients admitted to the hospital with acute coronary syndrome |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Group/Cohort (s) |
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| Publications * |
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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 | 20000 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| 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 | NCT00713557 | ||||
| Other Study ID Numbers ICMJE | RJH | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Wei Feng Shen, MD, PhD, Professor in Medicine, Ruijin Hospital, Shanghai Jiaotong University School of Medicine | ||||
| Study Sponsor ICMJE | Shanghai Jiao Tong University School of Medicine | ||||
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| Investigators ICMJE |
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| Information Provided By | Shanghai Jiao Tong University School of Medicine | ||||
| Verification Date | January 2011 | ||||
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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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