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TerminatedNCT00713557Updated Oct 13, 2016

Shanghai Registry of Acute Coronary Events

An observational study in Coronary Artery Disease and Acute Coronary Syndrome, sponsored by Shanghai Jiao Tong University School of Medicine. Terminated at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-10-13.

Sponsored by Shanghai Jiao Tong University School of Medicine · Observational

Why this study was terminated
devices applied in the study were no more available in the market, and medical intervention section was completed.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Coronary Artery Disease
  • Acute Coronary Syndrome

Keywords

  • coronary angioplasty
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In context

Coronary Artery Disease

5,600 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients admitted to the hospital with acute coronary syndrome

Inclusion criteria

  • patients admitted to the hospital with acute coronary syndrome and received medical or interventional treatment

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20,000 participants (estimated)

Groups and cohorts

  • 1

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

    Device: 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

    Device: drug-eluting stent · Drug: Tirofiban

  • 3

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

    Device: drug-eluting stent

  • 4

    patients with non ST-elevation ACS treated by elective PCI

    Device: 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.

  • 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).

Interventions

  • Devicedrug-eluting stent

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

    Also known as: Cypher stent, Taxus stent, Firebird stent, Excel stent

  • DrugTirofiban

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

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. stroke, stent thrombosis

    Time frame: in-hospital, 30d, and long-term follow-up

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Study locations

1 site
  • Dept. of Cardiology, Ruijin Hospital
    Shanghai, Shanghai 200025, China
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References and documents

Publications

  • 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. PubMed 18364130 ↗
  • 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. PubMed 21521833 ↗
  • 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. PubMed 21518584 ↗
  • 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. PubMed 24697948 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00713557
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Ministry of Science and Technology of the People´s Republic of China, Changhai Hospital
Responsible party
Zhang Qi, MD (MD, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Jul 11, 2008
Start date
Mar 2005
Primary completion
Jan 2018 (estimated)
Last update
Oct 13, 2016

Study contacts

Wei Feng Shen, MD,PhD
principal investigator · Ruijin Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.

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