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
  Purpose

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 Intervention
Coronary Artery Disease
Acute Coronary Syndrome
Device: drug-eluting stent
Drug: Tirofiban

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase 4 Study to Compare Different Therapeutic Strategies for Patients With ACS

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • stroke, stent thrombosis [ Time Frame: in-hospital, 30d, and long-term follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20000
Study Start Date: March 2005
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients admitted to the hospital with acute coronary syndrome

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713557

Contacts
Contact: Qi Zhang, MD, PhD 86-21-64370045 ext 665301 zhangqnh@yahoo.com

Locations
China, Shanghai
Dept. of Cardiology, Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Xin Chen, MD    86-21-64370045 ext 665318    rjheart@gmail.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Ministry of Science and Technology of the People´s Republic of China
Changhai Hospital
Investigators
Principal Investigator: Wei Feng Shen, MD,PhD Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wei Feng Shen, MD, PhD, Professor in Medicine, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
ClinicalTrials.gov Identifier: NCT00713557     History of Changes
Other Study ID Numbers: RJH
Study First Received: July 7, 2008
Last Updated: June 15, 2011
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
coronary angioplasty

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Tirofiban
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014