The Evaluation and Management of Patients With Acute Chest Pain in China

Acute Coronary Syndrome Clinical Trial

Official title:

The Evaluation and Management of Patients With Acute Chest Pain in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02384863
• Other study ID #: 201502032
• Secondary ID: ChiCTR-IOQ-14005
• Status: Recruiting
• Phase: N/A
• First received: February 26, 2015
• Last updated: March 9, 2015
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2015
• Source: Qilu Hospital
• Contact: Yuguo Chen, M.D., Ph.D.
• Phone: 86-18678812777
• Email: chen919085[@]126.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to describe the characteristics, evaluation, management and outcomes of acute chest pain, and to provide opportunities for future initiatives to improve the emergency care for patients experiencing acute chest pain in China.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18000
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Acute chest pain(pain in the area inferior to the clavicle, superior to the rib arch, and anterior to the bilateral posterior axillary line);

• Possible Acute Coronary Syndrome;

• Symptoms occurring within last 24 hours;

• Informed consent from patient or next of kin.

Exclusion Criteria:

• Arrhythmia or heart failure not cause by myocardial ischemia;

• Confirmed lung disease without chest pain;

• No onset of symptoms within last 24 hours;

• No written consensus.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Chest Pain

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan
China	First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Henan Provincial Hospital	Zhengzhou	Henan

Sponsors (9)

Lead Sponsor	Collaborator
Yuguo Chen	First Affiliated Hospital of Harbin Medical University, Henan Provincial Hospital, National Health and Family Planning Commission, P.R.China, Second Affiliated Hospital of Xi'an Jiaotong University, Shandong University, Shanghai Chest Hospital, West China Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-hospital mortality		During hospital stay,an expected average of 7 days	Yes
Secondary	Time between symptom onset and hospital admission		Time interval from symptom onset to arrival at the Emergency Department,an expected median of 9 hours	No
Secondary	Major adverse cardiac events (MACE)	Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization	1 year	Yes
Secondary	Cost-Effectiveness Analysis	To study the cost-effectiveness ratios of diagnostic and management strategies for patients with acute chest pain	1 year	Yes