The Evaluation and Management of Patients With Acute ChesT Pain in China (EMPACT)

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome; Acute Chest Pain

• Study Type: Observational
• Enrollment (Actual): 8374

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Qilu Hospital of Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse cardiac events (MACE)	The primary outcome was a composite of adjudicated MACEs, including death from all causes, non-fatal acute myocardial infarction (AMI), urgent revascularization, stroke, cardiac arrest, and cardiogenic shock.	30 days after presenting to the emergency departments(ED)

Secondary Outcome Measures

Outcome Measure	Time Frame
revisiting to ED and rehospitalization	30 days after presenting to the EDs

Collaborators and Investigators

• Sponsor: Yuguo Chen
• Collaborators: Qilu Hospital of Shandong University; Qianfoshan Hospital; Jining Medical University; Linyi People's Hospital; Central Hospital of Zibo; People's Hospital of Jinxiang County; People's Hospital of Chengwu; Traditional Chinese Medicine Hospital of Wucheng County; People's Hospital of Longkou City; People's Hospital of Gaomi City; People's Hospital of Wenshang County; The 2nd People's Hospital of Liaocheng City; People's Hospital of Shouguang City; Traditional Chinese Medicine Hospital of Pingyin County; Traditional Chinese Medicine Hospital of Laoling City; The 2nd People's Hospital of Dongying City; Affiliated Hospital of Shandong Academy of Medical Sciences; People's Hospital of Shizhong District, Jinan City; The 2nd People's Hospital of Dezhou City; People's Hospital of Mudan, Heze City; The 3rd People's Hospital of Jinan City; Xinlongzhuang Colliery Hospital; The 2nd Traditional Chinese Medicine Hospital of Taian City
• Investigators: Study Chair: Yuguo Chen, M.D., Ph.D, Qilu Hospital of Shandong University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2016
• Primary Completion (ACTUAL): October 1, 2017
• Study Completion (ACTUAL): October 1, 2017

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: August 27, 2015
• First Posted (ESTIMATE): September 1, 2015

Study Record Updates

• Last Update Posted (ACTUAL): January 9, 2018
• Last Update Submitted That Met QC Criteria: January 6, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Acute Coronary Syndrome; Decision Aid; Healthcare Utilization; Evaluation and Management; Acute Chest Pain
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Acute Coronary Syndrome
• Other Study ID Numbers: QLEmer201507