Chest PainPEACPNCT04122573
Prospective Multicenter Study for Early Evaluation of Acute Chest Pain
An observational study of Chest Pain and Acute Aortic Dissection, run by West China Hospital at 9 sites in China.
Trial summary
In this study, clinical database and blood sample bank of acute chest pain (ACP) will be established at chest pain center of multi-center hospital. To explore new biomarkers and screen clinical indicators with effective risk stratification and prognostic evaluation for ACP through proteomics technology and statistics… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chest Pain, Acute Aortic Dissection, Pulmonary Embolism
- What is being tested?
- Coronary angiography, CT angiography of aorta and CT angiography of pulmonary arteries.
- How many people
- 10,000 participants
- Where
- 9 sitesChina
- Study dates
- 1 Nov 2019to 31 Oct 2022
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population in this study is characterized by acute chest pain as the first symptom for consultation. These are mainly Han and Tibetan patients from southwest China. The study population included first-visit and referral patients.
Who may be able to join
- Patient aged 18-90 years old;
- The time from onset of symptoms to emergency room is less than 24 hours.
Who cannot join
- Patients complicate with end-stage neoplastic diseases;
- Pregnant women;
- Patients re-visit during the selection period;
- Patients refuse to participate in this study.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Chengdu Second People's Hospital
Chengdu, Sichuan, 610021
Ling Li, MBBS, +86-028-67830120, 117754652@qq.com
- Recruiting
Chengdu Shangjin Nanfu Hospital
Chengdu, Sichuan, 610041
Rongsheng Du, MD, +86-028-62539407, 793203755@qq.com
- Recruiting
Sichuan Integrative Medicine Hospital
Chengdu, Sichuan, 610041
Jing Yu, MBBS, +86-028-63160059, yujing5126@foxmail.com
- Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Dongze Li, MBBS, +86-28-85422461, dongze.li@ymail.com
Yu Jia, MBBS, +86-18080085361, 453986149@qq.com
- Recruiting
People's Hospital of Xindu District
Chengdu, Sichuan, 610500
Fangmin Fan, MBBS, +86-028-83993061, 54907851@qq.com
- Recruiting
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646099
Ying Liu, MD, +86-0830-3165851, liu61213@163.com
- Recruiting
Panzhihua Central Hospital
Panzhihua, Sichuan, 617000
Zhengli Luo, MBBS, +86-0812-2238148, 878838423@qq.com
- Recruiting
Zigong Fourth People's Hospital
Zigong, Sichuan, 643000
Ping Xu, MD, +86-0813-2401126, 58124453@qq.com
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Haizhen Duan, MD, +86-028-8649999, dhzh1027@163.com
About this study
In this study, clinical database and blood sample bank of acute chest pain (ACP) will be established at chest pain center of multi-center hospital. To explore new biomarkers and screen clinical indicators with effective risk stratification and prognostic evaluation for ACP through proteomics technology and statistics methods. Risk stratification and short-term and long-term prognostic evaluation models for high-risk ACP will be established using large data analysis.
Read the 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.
- Conditions
- Chest Pain, Acute Aortic Dissection, Pulmonary Embolism, Acute Myocardial Infarction Type 1, Acute Coronary Syndrome
- Being tested
- Coronary angiography, CT angiography of aorta, CT angiography of pulmonary arteries., Electrocardiogram, Cardiac Troponin
- Keywords
- Chest pain, Acute Aortic Dissection, Pulmonary Embolism, Acute Coronary Syndrome, Acute myocardial infarction, Risk stratification, Prognosis, Biomarkers
- Medical subject headings
- Chest Pain, Pulmonary Embolism, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary angiographyDiagnostic test
Acute chest pain patients, suspected acute coronary syndrome, are diagnosed by coronary angiography.
CT angiography of aortaDiagnostic test
Also called CTA
Acute chest pain patients, suspected acute aortic dissection, are diagnosed by gold standard of CTA.
CT angiography of pulmonary arteries.Diagnostic test
Also called CTA
Acute chest pain patients, suspected acute pulmonary embolism, are diagnosed by gold standard of CTA.
ElectrocardiogramDiagnostic test
Also called ECG
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.
Cardiac TroponinDiagnostic test
Also called Biomarkers of myocardial injury
Dynamic changes of cardiac troponin I and/or T will be used in the diagnosis of acute myocardial infarction
| Study group | Role | What they receive |
|---|---|---|
| Acute chest pain | The population in this study are characterized by acute chest pain as the first symptom for consultation within 24 hours. Receives: Diagnostic Test: Coronary angiography; Diagnostic Test: CT angiography of aorta; Diagnostic Test: CT angiography of pulmonary arteries.; Diagnostic Test: Electrocardiogram; Diagnostic Test: Cardiac Troponin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participants with all-cause death
Patients die of all causes during hospitalization or follow-up
Measured: One year
Rate of participants with cardiovascular death
Patients die of cardiac and cerebrovascular diseases during hospitalization or follow-up
Measured: One year
Rate of participants with major adverse cardiac events (MACEs)
MACEs include cardiac death, stroke, and recurrent myocardial infarction.
Measured: One year
Rate of participants with acute myocardial infarction
Chest pain patients are diagnosed as acute myocardial infarction based on fourth edition of guidelines for myocardial infarction
Measured: Twenty-four hours
Rate of participants with acute pulmonary embolism
Chest pain patients are diagnosed as acute pulmonary embolism based on CT of pulmonary angiography.
Measured: Twenty-four hours
Rate of participants with acute aortic dissection
Chest pain patients are diagnosed as acute aortic dissection based on CT of aortic angiography.
Measured: Twenty-four hours
Rate of participants with acute coronary syndrome
Chest pain patients are diagnosed as acute coronary syndrome based on European Society of Cardiology (ESC) guidelines.
Measured: Twenty-four hours
Secondary outcomes (12)
Rate of participants with ischemia or necrosis of lower limbs
Patients complicate with ischemia or necrosis of lower limbs during hospitalization
Measured: Two weeks
Rate of participants with acute heart failure
Patients complicate with acute heart failure during hospitalization
Measured: Two weeks
Rate of participants with revascularization
Patients receive revascularization for recurrent angina or myocardial infarction during hospitalization
Measured: Two weeks
Rate of participants with consciousness disorder
Patients complicate with consciousness disorder during hospitalization
Measured: Two weeks
Rate of participants with cardiogenic shock
Patients complicate with cardiogenic shock during hospitalization
Measured: Two weeks
Rate of participants with acute kidney injury
Patients complicate with acute kidney injury during hospitalization
Measured: Two weeks
Rate of participants with malignant arrhythmia
Patients complicate with malignant arrhythmia during hospitalization
Measured: Two weeks
Rate of participants with pericardial tamponade
Patients complicate with pericardial tamponade during hospitalization
Measured: Two weeks
Rate of participants with bleeding
Patients complicate with bleeding
Measured: One year
Rate of participants with multiple organ dysfunction syndrome
Patients complicate with multiple organ dysfunction syndrome during hospitalization
Measured: Two weeks
Rate of participants with respiratory failure
Patients complicate with respiratory failure during hospitalization
Measured: Two weeks
Rate of participants with cardiac arrest
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.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Nov 2019
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- 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
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dongze Li, West China Hospital
- Investigators
- Dongze Li, MBBS, Principal investigator, Emergency Department, West China Hospital, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122573
- Sponsor's protocol ID
- WestChinaH1
- Acronym
- PEACP
- Status last verified
- Nov 2019
- First submitted
- 6 Oct 2019
- Last updated
- 29 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study will share individual participant data (IPD) including patient characteristics, vital signs, laboratory examinations, imaging examinations, diagnosis, adverse events in hospital and long-term prognosis.
Publications
Li F, Li D, Yu J, Jia Y, Wen J, Li W, Tong Y, Wu J, Wan Z, Cao Y, Zhang Q, Zeng R. Association Between Plasma Ceramides and One-Year Mortality in Patients with Acute Coronary Syndrome: Insight from the PEACP Study. Clin Interv Aging. 2023 Apr 6;18:571-584. doi: 10.2147/CIA.S402253. eCollection 2023.
PubMed 37050937
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Study for Early Evaluation of Acute Chest Pain
- ClinicalTrials.gov ID
- NCT04122573
- Acronym / sponsor ID
- PEACP / WestChinaH1
- Conditions
- Chest Pain, Acute Aortic Dissection, Pulmonary Embolism, Acute Myocardial Infarction Type 1, Acute Coronary Syndrome
- Keywords
- Chest pain, Acute Aortic Dissection, Pulmonary Embolism, Acute Coronary Syndrome, Acute myocardial infarction, Risk stratification, Prognosis, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 10 Oct 2019 (actual)
- 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.
In this study, clinical database and blood sample bank of acute chest pain (ACP) will be established at chest pain center of multi-center hospital. To explore new biomarkers and screen clinical indicators with effective risk stratification and prognostic evaluation for ACP through proteomics technology and statistics methods. Risk stratification and short-term and long-term prognostic evaluation models for high-risk ACP will be established using large data analysis.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute chest pain | – | Diagnostic Test: Coronary angiography, Diagnostic Test: CT angiography of aorta, Diagnostic Test: CT angiography of pulmonary arteries., Diagnostic Test: Electrocardiogram, Diagnostic Test: Cardiac TroponinThe population in this study are characterized by acute chest pain as the first symptom for consultation within 24 hours. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population in this study is characterized by acute chest pain as the first symptom for consultation. These are mainly Han and Tibetan patients from southwest China. The study population included first-visit and referral patients.
Key inclusion criteria (2 listed)
- Patient aged 18-90 years old;
- The time from onset of symptoms to emergency room is less than 24 hours.
Key exclusion criteria (4 listed)
- Patients complicate with end-stage neoplastic diseases;
- Pregnant women;
- Patients re-visit during the selection period;
- Patients refuse to participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary angiographyAcute chest pain patients, suspected acute coronary syndrome, are diagnosed by coronary angiography. | Diagnostic test | Acute chest pain |
| CT angiography of aortaAlso: CTAAcute chest pain patients, suspected acute aortic dissection, are diagnosed by gold standard of CTA. | Diagnostic test | Acute chest pain |
| CT angiography of pulmonary arteries.Also: CTAAcute chest pain patients, suspected acute pulmonary embolism, are diagnosed by gold standard of CTA. | Diagnostic test | Acute chest pain |
| ElectrocardiogramAlso: ECGAll patients with acute chest pain will subject to ECG examination within 10 minutes of admission, which can quickly screen ST-segment elevation myocardial infarction. | Diagnostic test | Acute chest pain |
| Cardiac TroponinAlso: Biomarkers of myocardial injuryDynamic changes of cardiac troponin I and/or T will be used in the diagnosis of acute myocardial infarction | Diagnostic test | Acute chest pain |
Primary outcome
Rate of participants with all-cause death
Time frame: One year
Patients die of all causes during hospitalization or follow-up
Rate of participants with cardiovascular death
Time frame: One year
Patients die of cardiac and cerebrovascular diseases during hospitalization or follow-up
Rate of participants with major adverse cardiac events (MACEs)
Time frame: One year
MACEs include cardiac death, stroke, and recurrent myocardial infarction.
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
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.
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.
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.
12 secondary outcomes
Rate of participants with ischemia or necrosis of lower limbs
Time frame: Two weeks
Rate of participants with acute heart failure
Time frame: Two weeks
Rate of participants with revascularization
Time frame: Two weeks
Rate of participants with consciousness disorder
Time frame: Two weeks
Rate of participants with cardiogenic shock
Time frame: Two weeks
Rate of participants with acute kidney injury
Time frame: Two weeks
Rate of participants with malignant arrhythmia
Time frame: Two weeks
Rate of participants with pericardial tamponade
Time frame: Two weeks
Rate of participants with bleeding
Time frame: One year
Rate of participants with multiple organ dysfunction syndrome
Time frame: Two weeks
Rate of participants with respiratory failure
Time frame: Two weeks
Rate of participants with cardiac arrest
Time frame: Two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2019.
- Derived from this study: PubMed 37050937Li F, Li D, Yu J, Jia Y, Wen J, Li W, Tong Y, Wu J, Wan Z, Cao Y, Zhang Q, Zeng R. Association Between Plasma Ceramides and One-Year Mortality in Patients with Acute Coronary Syndrome: Insight from the PEACP Study. Clin Interv Aging. 2023 Apr 6;18:571-584. doi: 10.2147/CIA.S402253. eCollection 2023.
- Individual participant dataSharing planned: Yes. This study will share individual participant data (IPD) including patient characteristics, vital signs, laboratory examinations, imaging examinations, diagnosis, adverse events in hospital and long-term prognosis.
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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.
Dongze Li, MBBS principal investigator
Emergency Department, West China Hospital, Sichuan University
9 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 Aortic Dissection, run by West China Hospital at 9 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 2 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 29 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Dongze Li, MBBS (+86-28-85422461, dongze.li@ymail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of participants with all-cause death (time frame: One year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04122573, which also lists 1 linked publication.
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 29 Nov 2019.