Clinical trial NCT02536677: The Evaluation and Management of Patients With Acute ChesT Pain in China
Official title: The Evaluation and Management of Patients With Acute ChesT Pain in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Chest Pain
Acute Coronary Syndrome
Keywords: Acute Chest Pain
Acute Coronary Syndrome
Evaluation and Management
Decision Aid
Healthcare Utilization
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: People's Hospital of Jinxiang County
name: People's Hospital of Chengwu
name: Traditional Chinese Medicine Hospital of Wucheng County
name: People's Hospital of Longkou City
name: People's Hospital of Gaomi City
name: Linyi People's Hospital
name: People's Hospital of Wenshang County
name: The 2nd People's Hospital of Liaocheng City
name: People's Hospital of Shouguang City
name: Traditional Chinese Medicine Hospital of Pingyin County
name: Traditional Chinese Medicine Hospital of Laoling City
name: The 2nd People's Hospital of Dongying City
name: Affiliated Hospital of Shandong Academy of Medical Sciences
name: People's Hospital of Shizhong District, Jinan City
name: The 2nd People's Hospital of Dezhou City
name: Central Hospital of Zibo
name: Jining Medical University
name: People's Hospital of Mudan, Heze City
name: The 3rd People's Hospital of Jinan City
name: Qianfoshan Hospital
name: Xinlongzhuang Colliery Hospital
name: The 2nd Traditional Chinese Medicine Hospital of Taian City
name: Qilu Hospital of Shandong University
First posted: 2015-09-01
Enrollment: 8374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We used a stratified random sampling design to generate a Shandong province representative sample of hospitals. Twenty two hospitals were randomly selected including 12 rural hospitals, 6 grade II and 4 grade III urban hospitals. One grade II-urban hospital refused to participate. As a coordinating center, Qilu Hospital of Shandong University participated in the study without being sampled. Finally, 22 hospitals were included.

A total of more than 10000 patients were anticipated to be consecutively enrolled from the participating hospitals over the course of the 12-month program. The beginning dates of enrollment in 22 centers were distributed from January, 2016 to September 2016.

Brief summary: EMPACT is the first attempt to comprehensively evaluate the current emergency care of acute chest pain from a regional representative sample in China.Findings will allow new opportunities to facilitate the clinical quality improvements and ultimately reduce the mortality and health care burden in patients with acute chest pain. It also will help to establish a regional network and database for further research and performance improvement.


Eligibility criteria: Inclusion criteria

1. Eighteen years and older
2. Presenting to the ED
3. With acute chest pain or suspected ACS
4. Symptoms occurring within 24 hours
5. Informed consent from patient or next of kin

Exclusion criteria

1. Chest pain caused by trauma
2. Persisting or recurrent chest pain caused by rheumatic diseases or cancer
3. Transferred from another grade II or grade III hospital
4. Presenting to the ED again within 30 days after initial enrollment

Primary outcomes:
measure: Major adverse cardiac events (MACE)
timeFrame: 30 days after presenting to the emergency departments(ED)
Secondary outcomes:
measure: revisiting to ED and rehospitalization
timeFrame: 30 days after presenting to the EDs
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yuguo Chen, M.D., Ph.D
role: STUDY_CHAIR
References:
citation: Zheng W, Wang J, Xu F, Zheng J, Zhang H, Ma J, Wang G, Wang H, Chew DP, Chen Y. Evaluation and management of patients with acute chest pain in China (EMPACT): protocol for a prospective, multicentre registry study. BMJ Open. 2018 Jan 23;8(1):e017872. doi: 10.1136/bmjopen-2017-017872.