Shanghai Registry of Acute Coronary Events

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Ministry of Science and Technology of the People´s Republic of China
Changhai Hospital
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT00713557
First received: July 7, 2008
Last updated: June 15, 2011
Last verified: January 2011

July 7, 2008
June 15, 2011
March 2005
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT00713557 on ClinicalTrials.gov Archive Site
stroke, stent thrombosis [ Time Frame: in-hospital, 30d, and long-term follow-up ] [ Designated as safety issue: Yes ]
Same as current
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Shanghai Registry of Acute Coronary Events
Phase 4 Study to Compare Different Therapeutic Strategies for Patients With ACS

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

patients admitted to the hospital with acute coronary syndrome

  • Coronary Artery Disease
  • Acute Coronary Syndrome
  • 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
  • 1
    patients with acute ST-elevation myocardial infarction and receiving primary percutaneous coronary intervention Subgroup: Patient Transferring vs. Physician Transferring strategy
    Intervention: 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
    Interventions:
    • Device: drug-eluting stent
    • Drug: Tirofiban
  • 3
    patients with non-ST-elevation ACS treated by immediate PCI
    Intervention: Device: drug-eluting stent
  • 4
    patients with non ST-elevation ACS treated by elective PCI
    Intervention: Device: drug-eluting stent

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20000
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Qi Zhang, MD, PhD 86-21-64370045 ext 665301 zhangqnh@yahoo.com
China
 
NCT00713557
RJH
Yes
Wei Feng Shen, MD, PhD, Professor in Medicine, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai Jiao Tong University School of Medicine
  • Ministry of Science and Technology of the People´s Republic of China
  • Changhai Hospital
Principal Investigator: Wei Feng Shen, MD,PhD Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai Jiao Tong University School of Medicine
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP