- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04122573
Prospective Multicenter Study for Early Evaluation of Acute Chest Pain (PEACP)
Study Overview
Status
Conditions
Detailed Description
In this study, acute chest pain (ACP) patients will be selected from chest pain center of nine large tertiary hospitals in China from November 1, 2019 to October 31, 2021. All the selected patients will sign the informed consent.
Patients' characteristics, the first vital signs at the time of consultation, the first arterial blood gas, complete blood count, coagulation markers, blood biochemical results and myocardial injury markers, imaging examinations and electrocardiogram will be collected within 30 minutes at admission. Meanwhile, whole blood and plasma samples will be collected and stored in - 80 ℃ refrigerator. After diagnosis according to the gold standard examination or related guidelines, patients will be admitted to different department for standard treatment. Medication, surgical procedures and complications will be recorded carefully. Plasma and whole blood will be used to detect proteomics and/or genomics biomarkers associated with early evaluation of ACP.
Screening early evaluation indicators using novel protein biomarkers and easy-to-obtain clinical indicators, and establishing evaluation models for high-risk ACP by data analysis methods. Area under the receiver operating characteristic curves (AUROC), net reclassification improvement (NRI), integrated discrimination improvement (IDI) and decision curve analysis (DCA) will be used to evaluate the prediction ability of the model.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Dongze Li, MBBS
- Phone Number: +86-28-85422461
- Email: dongze.li@ymail.com
Study Contact Backup
- Name: Yisong Cheng, MBBS
- Phone Number: +86-19983154487
- Email: yisongcheng01@163.com
Study Locations
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Guizhou
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Zunyi, Guizhou, China, 563000
- Recruiting
- Affiliated Hospital of Zunyi Medical University
-
Contact:
- Haizhen Duan, MD
- Phone Number: +86-028-8649999
- Email: dhzh1027@163.com
-
-
Sichuan
-
Chengdu, Sichuan, China, 610041
- Recruiting
- West China Hospital, Sichuan University
-
Contact:
- Dongze Li, MBBS
- Phone Number: +86-28-85422461
- Email: dongze.li@ymail.com
-
Contact:
- Yu Jia, MBBS
- Phone Number: +86-18080085361
- Email: 453986149@qq.com
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Chengdu, Sichuan, China, 610021
- Recruiting
- Chengdu Second People's Hospital
-
Contact:
- Ling Li, MBBS
- Phone Number: +86-028-67830120
- Email: 117754652@qq.com
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Chengdu, Sichuan, China, 610041
- Recruiting
- Chengdu Shangjin Nanfu Hospital
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Contact:
- Rongsheng Du, MD
- Phone Number: +86-028-62539407
- Email: 793203755@qq.com
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Chengdu, Sichuan, China, 610041
- Recruiting
- Sichuan Integrative Medicine Hospital
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Contact:
- Jing Yu, MBBS
- Phone Number: +86-028-63160059
- Email: yujing5126@foxmail.com
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Chengdu, Sichuan, China, 610500
- Recruiting
- People's Hospital of Xindu District
-
Contact:
- Fangmin Fan, MBBS
- Phone Number: +86-028-83993061
- Email: 54907851@qq.com
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Luzhou, Sichuan, China, 646099
- Recruiting
- Affiliated Hospital of Southwest Medical University
-
Contact:
- Ying Liu, MD
- Phone Number: +86-0830-3165851
- Email: liu61213@163.com
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Panzhihua, Sichuan, China, 617000
- Recruiting
- Panzhihua Central Hospital
-
Contact:
- Zhengli Luo, MBBS
- Phone Number: +86-0812-2238148
- Email: 878838423@qq.com
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Zigong, Sichuan, China, 643000
- Recruiting
- Zigong Fourth People's Hospital
-
Contact:
- Ping Xu, MD
- Phone Number: +86-0813-2401126
- Email: 58124453@qq.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patient aged 18-90 years old;
- The time from onset of symptoms to emergency room is less than 24 hours.
Exclusion Criteria:
- Patients complicate with end-stage neoplastic diseases;
- Pregnant women;
- Patients re-visit during the selection period;
- Patients refuse to participate in this study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Acute chest pain
The population in this study are characterized by acute chest pain as the first symptom for consultation within 24 hours.
|
Acute chest pain patients, suspected acute coronary syndrome, are diagnosed by coronary angiography.
Acute chest pain patients, suspected acute aortic dissection, are diagnosed by gold standard of CTA.
Other Names:
Acute chest pain patients, suspected acute pulmonary embolism, are diagnosed by gold standard of CTA.
Other Names:
All patients with acute chest pain will subject to ECG examination within 10 minutes of admission, which can quickly screen ST-segment elevation myocardial infarction.
Other Names:
Dynamic changes of cardiac troponin I and/or T will be used in the diagnosis of acute myocardial infarction
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of participants with all-cause death
Time Frame: One year
|
Patients die of all causes during hospitalization or follow-up
|
One year
|
Rate of participants with cardiovascular death
Time Frame: One year
|
Patients die of cardiac and cerebrovascular diseases during hospitalization or follow-up
|
One year
|
Rate of participants with major adverse cardiac events (MACEs)
Time Frame: One year
|
MACEs include cardiac death, stroke, and recurrent myocardial infarction.
|
One year
|
Rate of participants with acute myocardial infarction
Time Frame: Twenty-four hours
|
Chest pain patients are diagnosed as acute myocardial infarction based on fourth edition of guidelines for myocardial infarction
|
Twenty-four hours
|
Rate of participants with acute pulmonary embolism
Time Frame: Twenty-four hours
|
Chest pain patients are diagnosed as acute pulmonary embolism based on CT of pulmonary angiography.
|
Twenty-four hours
|
Rate of participants with acute aortic dissection
Time Frame: Twenty-four hours
|
Chest pain patients are diagnosed as acute aortic dissection based on CT of aortic angiography.
|
Twenty-four hours
|
Rate of participants with acute coronary syndrome
Time Frame: Twenty-four hours
|
Chest pain patients are diagnosed as acute coronary syndrome based on European Society of Cardiology (ESC) guidelines.
|
Twenty-four hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of participants with ischemia or necrosis of lower limbs
Time Frame: Two weeks
|
Patients complicate with ischemia or necrosis of lower limbs during hospitalization
|
Two weeks
|
Rate of participants with acute heart failure
Time Frame: Two weeks
|
Patients complicate with acute heart failure during hospitalization
|
Two weeks
|
Rate of participants with revascularization
Time Frame: Two weeks
|
Patients receive revascularization for recurrent angina or myocardial infarction during hospitalization
|
Two weeks
|
Rate of participants with consciousness disorder
Time Frame: Two weeks
|
Patients complicate with consciousness disorder during hospitalization
|
Two weeks
|
Rate of participants with cardiogenic shock
Time Frame: Two weeks
|
Patients complicate with cardiogenic shock during hospitalization
|
Two weeks
|
Rate of participants with acute kidney injury
Time Frame: Two weeks
|
Patients complicate with acute kidney injury during hospitalization
|
Two weeks
|
Rate of participants with malignant arrhythmia
Time Frame: Two weeks
|
Patients complicate with malignant arrhythmia during hospitalization
|
Two weeks
|
Rate of participants with pericardial tamponade
Time Frame: Two weeks
|
Patients complicate with pericardial tamponade during hospitalization
|
Two weeks
|
Rate of participants with bleeding
Time Frame: One year
|
Patients complicate with bleeding
|
One year
|
Rate of participants with multiple organ dysfunction syndrome
Time Frame: Two weeks
|
Patients complicate with multiple organ dysfunction syndrome during hospitalization
|
Two weeks
|
Rate of participants with respiratory failure
Time Frame: Two weeks
|
Patients complicate with respiratory failure during hospitalization
|
Two weeks
|
Rate of participants with cardiac arrest
Time Frame: Two weeks
|
The sudden termination of cardiac ejection function, the disappearance of great artery pulsation and heart sound, and severe ischemia and hypoxia of important organs (such as brain) lead to the termination of life.
|
Two weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of stay
Time Frame: Two weeks
|
Time between patient's visit and discharge
|
Two weeks
|
Rate of re-admitted participants
Time Frame: Six months
|
Re-admission after discharge within 6 months
|
Six months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dongze Li, MBBS, Emergency Department, West China Hospital, Sichuan University
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Pain
- Neurologic Manifestations
- Embolism and Thrombosis
- Aneurysm
- Myocardial Infarction
- Infarction
- Embolism
- Chest Pain
- Acute Coronary Syndrome
- Aneurysm, Dissecting
- Pulmonary Embolism
Other Study ID Numbers
- WestChinaH1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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