NCT00713557

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2008

Completed
9.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

12.8 years

First QC Date

July 7, 2008

Last Update Submit

October 12, 2016

Conditions

Keywords

coronary angioplasty

Outcome Measures

Primary Outcomes (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 Outcomes (1)

  • stroke, stent thrombosis

    in-hospital, 30d, and long-term follow-up

Study Arms (6)

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 stentDrug: 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

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
1234

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

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients admitted to the hospital with acute coronary syndrome

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Cardiology, Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Coronary Artery DiseaseAcute Coronary Syndrome

Interventions

Drug-Eluting StentsTirofiban

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and SuppliesTyrosineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Wei Feng Shen, MD,PhD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 7, 2008

First Posted

July 11, 2008

Study Start

March 1, 2005

Primary Completion

January 1, 2018

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations