Shanghai Registry of Acute Coronary Events

This study is currently recruiting participants.

Verified by Shanghai Jiao Tong University School of Medicine, February 2009

First Received: July 7, 2008 Last Updated: February 3, 2009 History of Changes

Sponsors and Collaborators:	Shanghai Jiao Tong University School of Medicine 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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

U.S. FDA Resources

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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	Device: drug-eluting stent drug-eluting stent, including sirolimus-eluting, paclitaxel-eluting and other types of China-made drug-eluting stent
2 patients with acute ST-elevation myocardial infarction treated by thrombolysis
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
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

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

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
Dept. of Cardiology, Ruijin Hospital	Recruiting
Shanghai, China, 200025
Contact: Xin Chen, MD 86-21-64370045 ext 665318 rjchenxin@yahoo.com.cn

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

Additional Information:

web recruiting system This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Ruijin Hospital, Shanghai Jiaotong University School of Medicine ( Wei Feng Shen, MD, PhD, Professor in Medicine )
Study ID Numbers:	RJH
Study First Received:	July 7, 2008
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00713557 History of Changes
Health Authority:	China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:

coronary angioplasty

Study placed in the following topic categories:

Sirolimus
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Paclitaxel
Myocardial Ischemia

Acute Coronary Syndrome
Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Pathologic Processes
Disease
Heart Diseases
Myocardial Ischemia

Syndrome
Acute Coronary Syndrome
Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on September 03, 2009