Chest PainNCT02384863
The Evaluation and Management of Patients With Acute Chest Pain in China
An observational study of Chest Pain and Acute Coronary Syndrome, run by Yuguo Chen at 7 sites in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chest Pain, Acute Coronary Syndrome
- How many people
- 18,000 participants
- Where
- 7 sitesChina
- Study dates
- Oct 2014to Dec 2016
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: consecutive patients attending the emergency department in 7 Chinese grade Ⅲ hospitals
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Not yet recruiting
West China Hospital
Chengdu, Sichuan, 610041
Yu Cao, M.D,Ph.D., 86-18980601184, yuyuer@126.com
Yu Cao, M.D,Ph.D.
- Not yet recruiting
First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Xiujie Wang, M.D,Ph.D, 86-13945690985, wangxiujie0709@sina.com
Xiujie Wang, M.D,Ph.D
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Yuguo Chen, M.D., Ph.D., 86-18678812777, chen919085@126.com
Yuguo Chen, M.D., Ph.D.
- Not yet recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Weiyi Fang, M.D,Ph.D, 86-13916688508, fwychest@163.com
Weiyi Fang, M.D,Ph.D
- Not yet recruiting
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Shuming Pan, M.D,Ph.D, 86-13801612110, drshumingpan@gmail.com
Shuming Pan, M.D,Ph.D
- Not yet recruiting
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004
Honghong Pei, M.D,Ph.D, 86-18991237562, 18991237562@163.com
Honghong Pei, M.D,Ph.D
- Not yet recruiting
Henan Provincial Hospital
Zhengzhou, Henan, 450003
Yingjie Chu, M.D,Ph.D, 86-13937199780, hnqbdsl@126.com
Yingjie Chu, M.D,Ph.D
About this study
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.
- Conditions
- Chest Pain, Acute Coronary Syndrome
- Keywords
- Chest Pain, Acute Coronary Syndrome, Cardiac, Emergency Department, Cardiac Testing, Healthcare Utilization, Patient Centered Outcomes, Shared Decision Making, Unnecessary hospital admissions, Decision Aid
- Medical subject headings
- Chest Pain, Acute Coronary Syndrome, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital mortality
Measured: During hospital stay,an expected average of 7 days
Secondary outcomes (3)
Time between symptom onset and hospital admission
Measured: Time interval from symptom onset to arrival at the Emergency Department，an expected median of 9 hours
Major adverse cardiac events (MACE)
Composite of major adverse cardiac events (MACE) including death, myocardial infarction and/or revascularization
Measured: 1 year
Cost-Effectiveness Analysis
To study the cost-effectiveness ratios of diagnostic and management strategies for patients with acute chest pain
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yuguo Chen
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Family Planning Commission, P.R.China, West China Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital, First Affiliated Hospital of Harbin Medical University, Second Affiliated Hospital of Xi'an Jiaotong University, Henan Provincial People's Hospital, Shandong University
- Responsible party
- Sponsor-investigator, Yuguo Chen, Qilu Hospital of Shandong University
- Investigators
- Yuguo Chen, M.D., Ph.D., Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384863
- Sponsor's protocol ID
- 201502032
- Other IDs
- ChiCTR-IOQ-14005268
- Status last verified
- Mar 2015
- First submitted
- 26 Feb 2015
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation and Management of Patients With Acute Chest Pain in China
- ClinicalTrials.gov ID
- NCT02384863
- Acronym / sponsor ID
- 201502032
- Conditions
- Chest Pain, Acute Coronary Syndrome
- Keywords
- Chest Pain, Acute Coronary Syndrome, Cardiac, Emergency Department, Cardiac Testing, Healthcare Utilization, Patient Centered Outcomes, Shared Decision Making
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 18,000 participants (estimated)
- Lead sponsor
- Yuguo ChenUniversity, hospital or other
- Collaborators
- National Health and Family Planning Commission, P.R.China, West China Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Chest Hospital, First Affiliated Hospital of Harbin Medical University, Second Affiliated Hospital of Xi'an Jiaotong University, Henan Provincial People's Hospital, Shandong University
- Study start
- Oct 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- consecutive patients attending the emergency department in 7 Chinese grade Ⅲ hospitals
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
in-hospital mortality
Time frame: During hospital stay,an expected average of 7 days
3 secondary outcomes
Time between symptom onset and hospital admission
Time frame: Time interval from symptom onset to arrival at the Emergency Department，an expected median of 9 hours
Major adverse cardiac events (MACE)
Time frame: 1 year
Cost-Effectiveness Analysis
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuguo Chen, M.D., Ph.D. study chair
Qilu Hospital of Shandong University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chest Pain and Acute Coronary Syndrome, run by Yuguo Chen at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuguo Chen, M.D., Ph.D. (86-18678812777, chen919085@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital mortality (time frame: During hospital stay,an expected average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.