Prospective Multicenter Study for Early Evaluation of Acute Chest Pain

NCT ID: NCT04122573

Last Updated: 2019-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-10-31

Brief Summary

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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

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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

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Chest Pain Acute Aortic Dissection Pulmonary Embolism Acute Myocardial Infarction Type 1 Acute Coronary Syndrome

Keywords

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Chest pain Acute Aortic Dissection Pulmonary Embolism Acute Coronary Syndrome Acute myocardial infarction Risk stratification Prognosis Biomarkers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute chest pain

The population in this study are characterized by acute chest pain as the first symptom for consultation within 24 hours.

Coronary angiography

Intervention Type DIAGNOSTIC_TEST

Acute chest pain patients, suspected acute coronary syndrome, are diagnosed by coronary angiography.

CT angiography of aorta

Intervention Type DIAGNOSTIC_TEST

Acute chest pain patients, suspected acute aortic dissection, are diagnosed by gold standard of CTA.

CT angiography of pulmonary arteries.

Intervention Type DIAGNOSTIC_TEST

Acute chest pain patients, suspected acute pulmonary embolism, are diagnosed by gold standard of CTA.

Electrocardiogram

Intervention Type DIAGNOSTIC_TEST

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 Troponin

Intervention Type DIAGNOSTIC_TEST

Dynamic changes of cardiac troponin I and/or T will be used in the diagnosis of acute myocardial infarction

Interventions

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Coronary angiography

Acute chest pain patients, suspected acute coronary syndrome, are diagnosed by coronary angiography.

Intervention Type DIAGNOSTIC_TEST

CT angiography of aorta

Acute chest pain patients, suspected acute aortic dissection, are diagnosed by gold standard of CTA.

Intervention Type DIAGNOSTIC_TEST

CT angiography of pulmonary arteries.

Acute chest pain patients, suspected acute pulmonary embolism, are diagnosed by gold standard of CTA.

Intervention Type DIAGNOSTIC_TEST

Electrocardiogram

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.

Intervention Type DIAGNOSTIC_TEST

Cardiac Troponin

Dynamic changes of cardiac troponin I and/or T will be used in the diagnosis of acute myocardial infarction

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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CTA CTA ECG Biomarkers of myocardial injury

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dongze Li

Lecturer, Clinical Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dongze Li, MBBS

Role: PRINCIPAL_INVESTIGATOR

Emergency Department, West China Hospital, Sichuan University

Locations

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Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Site Status RECRUITING

Chengdu Second People's Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Chengdu Shangjin Nanfu Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Sichuan Integrative Medicine Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

People's Hospital of Xindu District

Chengdu, Sichuan, China

Site Status RECRUITING

Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Site Status RECRUITING

Panzhihua Central Hospital

Panzhihua, Sichuan, China

Site Status RECRUITING

Zigong Fourth People's Hospital

Zigong, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dongze Li, MBBS

Role: CONTACT

Phone: +86-28-85422461

Email: [email protected]

Yisong Cheng, MBBS

Role: CONTACT

Phone: +86-19983154487

Email: [email protected]

Facility Contacts

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Haizhen Duan, MD

Role: primary

Ling Li, MBBS

Role: primary

Rongsheng Du, MD

Role: primary

Jing Yu, MBBS

Role: primary

Dongze Li, MBBS

Role: primary

Yu Jia, MBBS

Role: backup

Fangmin Fan, MBBS

Role: primary

Ying Liu, MD

Role: primary

Zhengli Luo, MBBS

Role: primary

Ping Xu, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37050937 (View on PubMed)

Other Identifiers

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WestChinaH1

Identifier Type: -

Identifier Source: org_study_id