Shanghai Registry of Acute Coronary Events

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT00713557
Collaborator
Ministry of Science and Technology of the PeopleĀ“s Republic of China (Other), Changhai Hospital (Other)
20,000
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Phase 4 Study to Compare Different Therapeutic Strategies for Patients With ACS
Study Start Date :
Mar 1, 2005
Anticipated Primary Completion Date :
Jan 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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
drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent
Other Names:
  • Cypher stent
  • Taxus stent
  • Firebird stent
  • Excel 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-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent
    Other Names:
  • Cypher stent
  • Taxus stent
  • Firebird stent
  • Excel stent
  • Drug: Tirofiban
    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

    Device: drug-eluting stent
    drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent
    Other Names:
  • Cypher stent
  • Taxus stent
  • Firebird stent
  • Excel stent
  • 4

    patients with non ST-elevation ACS treated by elective PCI

    Device: drug-eluting stent
    drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent
    Other Names:
  • Cypher stent
  • Taxus stent
  • Firebird stent
  • Excel 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).

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. stroke, stent thrombosis [in-hospital, 30d, and long-term follow-up]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dept. of Cardiology, Ruijin Hospital Shanghai Shanghai China 200025

    Sponsors and Collaborators

    • Shanghai Jiao Tong University School of Medicine
    • Ministry of Science and Technology of the PeopleĀ“s Republic of China
    • Changhai Hospital

    Investigators

    • Principal Investigator: Wei Feng Shen, MD,PhD, Ruijin Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhang Qi, MD, MD, Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT00713557
    Other Study ID Numbers:
    • RJH
    First Posted:
    Jul 11, 2008
    Last Update Posted:
    Oct 13, 2016
    Last Verified:
    Oct 1, 2016
    Keywords provided by Zhang Qi, MD, MD, Shanghai Jiao Tong University School of Medicine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2016