Shanghai Registry of Acute Coronary Events

October 12, 2016 updated by: Zhang Qi, MD, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Dept. of Cardiology, Ruijin Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients admitted to the hospital with acute coronary syndrome

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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:
  • Taxus stent
  • Cypher 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:
  • Taxus stent
  • Cypher 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:
  • Taxus stent
  • Cypher 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:
  • Taxus stent
  • Cypher 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
in-hospital, 30d, and long-term follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
stroke, stent thrombosis
Time Frame: in-hospital, 30d, and long-term follow-up
in-hospital, 30d, and long-term follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Changhai Hospital
Ministry of Science and Technology of the People´s Republic of China

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 10, 2008

First Posted (Estimate)

July 11, 2008

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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