Shanghai Registry of Acute Coronary Events

Coronary Artery Disease Clinical Trial

Official title:

Phase 4 Study to Compare Different Therapeutic Strategies for Patients With ACS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00713557
• Other study ID #: RJH
• Status: Terminated
• Phase: N/A
• First received: July 7, 2008
• Last updated: October 12, 2016
• Start date: March 2005

Study information

• Verified date: October 2016
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20000
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• drug-eluting stent
drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent

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

Locations

Country	Name	City	State
China	Dept. of Cardiology, Ruijin Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Changhai Hospital, Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

References & Publications (3)

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 coron — View Citation

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-s — View Citation

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 eleva — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse cardiac events(MACE), including death, non-fatal re-MI, and target vessel revascularization		in-hospital, 30d, and long-term follow-up	Yes
Secondary	stroke, stent thrombosis		in-hospital, 30d, and long-term follow-up	Yes

External Links

•   web recruiting system