Shanghai Registry of Acute Coronary Events

NCT ID: NCT00713557

Last Updated: 2016-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

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.

Conditions

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Coronary Artery Disease Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

patients with acute ST-elevation myocardial infarction and receiving primary percutaneous coronary intervention Subgroup: Patient Transferring vs. Physician Transferring strategy

drug-eluting stent

Intervention Type DEVICE

drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent

2

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

drug-eluting stent

Intervention Type DEVICE

drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent

Tirofiban

Intervention Type DRUG

upstream (in emergency room) versus downstream (in catheterization lab) intra-coronary loading versus conventional intravenous loading

3

patients with non-ST-elevation ACS treated by immediate PCI

drug-eluting stent

Intervention Type DEVICE

drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent

4

patients with non ST-elevation ACS treated by elective PCI

drug-eluting stent

Intervention Type DEVICE

drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent

5

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.

No interventions assigned to this group

6

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).

No interventions assigned to this group

Interventions

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drug-eluting stent

drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent

Intervention Type DEVICE

Tirofiban

upstream (in emergency room) versus downstream (in catheterization lab) intra-coronary loading versus conventional intravenous loading

Intervention Type DRUG

Other Intervention Names

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Cypher stent Taxus stent Firebird stent Excel stent

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and Technology of the People“s Republic of China

OTHER_GOV

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Zhang Qi, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Feng Shen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

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Dept. of Cardiology, Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Zhang Q, Zhang RY, Qiu JP, Zhang JF, Wang XL, Jiang L, Liao ML, Zhang JS, Hu J, Yang ZK, Shen WF. Prospective multicenter randomized trial comparing physician versus patient transfer for primary percutaneous coronary intervention in acute ST-segment elevation myocardial infarction. Chin Med J (Engl). 2008 Mar 20;121(6):485-91.

Reference Type RESULT
PMID: 18364130 (View on PubMed)

Zhang Q, Zhang RY, Qiu JP, Zhang JF, Wang XL, Jiang L, Liao ML, Zhang JS, Hu J, Yang ZK, Shen WF. One-year clinical outcome of interventionalist- versus patient-transfer strategies for primary percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction: results from the REVERSE-STEMI study. Circ Cardiovasc Qual Outcomes. 2011 May;4(3):355-62. doi: 10.1161/CIRCOUTCOMES.110.958785. Epub 2011 Apr 26.

Reference Type RESULT
PMID: 21521833 (View on PubMed)

Qiu JP, Zhang Q, Lu JD, Wang HR, Lin J, Ge ZR, Zhang RY, Shen WF. Direct ambulance transport to catheterization laboratory reduces door-to-balloon time in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention: the DIRECT-STEMI study. Chin Med J (Engl). 2011 Mar;124(6):805-10.

Reference Type RESULT
PMID: 21518584 (View on PubMed)

Zhang Q, Qiu JP, Kirtane AJ, Zhu TQ, Zhang RY, Yang ZK, Hu J, Ding FH, DU R, Shen WF. Comparison of biodegradable polymer versus durable polymer sirolimus-eluting stenting in patients with acute st-elevation myocardial infarction undergoing primary percutaneous coronary intervention: results of the RESOLVE study. J Interv Cardiol. 2014 Apr;27(2):131-41. doi: 10.1111/joic.12102.

Reference Type DERIVED
PMID: 24697948 (View on PubMed)

Other Identifiers

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RJH

Identifier Type: -

Identifier Source: org_study_id

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