Shanghai Registry of Acute Coronary Events

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 4 Study to Compare Different Therapeutic Strategies for Patients With ACS

Conditions
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Coronary Artery Disease, Acute Coronary Syndrome

Intervention / Treatment
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* Device: drug-eluting stent
* Drug: Tirofiban


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients admitted to the hospital with acute coronary syndrome and received medical or interventional treatment Exclusion Criteria: non ACS patients; complicated with other lethal disease predicted life span less than 12 months known allergy history to any anti-platelet or anti-thrombin medicine unconscious at the time of arrival at the hospital

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients with acute ST-elevation myocardial infarction and receiving primary percutaneous coronary intervention Subgroup: Patient Transferring vs. Physician Transferring strategy | Device: drug-eluting stent<br>* drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent<br>* Other names: Excel stent;|
| 2<br>patients with acute ST-elevation myocardial infarction treated by thrombolysis or facilitated PCI Subgroup: upstream use of Tirofiban + primary PCI vs. downstream use of tirofiban + primary PCI | Device: drug-eluting stent<br>* drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent<br>* Other names: Excel stent;Drug: Tirofiban<br>* upstream (in emergency room) versus downstream (in catheterization lab) intra-coronary loading versus conventional intravenous loading<br>|
| 3<br>patients with non-ST-elevation ACS treated by immediate PCI | Device: drug-eluting stent<br>* drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent<br>* Other names: Excel stent;|
| 4<br>patients with non ST-elevation ACS treated by elective PCI | Device: drug-eluting stent<br>* drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent<br>* Other names: Excel stent;|
| 5<br>STEMI patient with multivessel disease, complete revascularization is planned to achieve during the index hospitalization.i.e.P-PCI for culprit lesion,combined with staged PCI for remaining diseased vessel. | |
| 6<br>STEMI patient with multivessel disease, complete revascularization is planned to achieve at 6 weeks after STEMI onset.i.e.P-PCI for culprit lesion during index hospitalization,combined with staged PCI for remaining diseased vessel at 6-week's follow-up(secondary hospitalization). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiac events(MACE), including death, non-fatal re-MI, and target vessel revascularization |  | in-hospital, 30d, and long-term follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke, stent thrombosis |  | in-hospital, 30d, and long-term follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary angioplasty