Prospective Multicenter Study for Early Evaluation of Acute Chest Pain (PEACP)

November 27, 2019 updated by: Dongze Li, West China Hospital
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.

Study Overview

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

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
        • Contact:
      • Chengdu, Sichuan, China, 610021
        • Recruiting
        • Chengdu Second People's Hospital
        • Contact:
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Chengdu Shangjin Nanfu Hospital
        • Contact:
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Sichuan Integrative Medicine Hospital
        • Contact:
      • Chengdu, Sichuan, China, 610500
        • Recruiting
        • People's Hospital of Xindu District
        • Contact:
      • Luzhou, Sichuan, China, 646099
        • Recruiting
        • Affiliated Hospital of Southwest Medical University
        • Contact:
      • Panzhihua, Sichuan, China, 617000
        • Recruiting
        • Panzhihua Central Hospital
        • Contact:
      • Zigong, Sichuan, China, 643000
        • Recruiting
        • Zigong Fourth People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • CTA
Acute chest pain patients, suspected acute pulmonary embolism, are diagnosed by gold standard of CTA.
Other Names:
  • CTA
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:
  • ECG
Dynamic changes of cardiac troponin I and/or T will be used in the diagnosis of acute myocardial infarction
Other Names:
  • Biomarkers of myocardial injury

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dongze Li, MBBS, Emergency Department, West China Hospital, Sichuan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ANTICIPATED)

October 31, 2021

Study Completion (ANTICIPATED)

October 31, 2022

Study Registration Dates

First Submitted

October 6, 2019

First Submitted That Met QC Criteria

October 9, 2019

First Posted (ACTUAL)

October 10, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 29, 2019

Last Update Submitted That Met QC Criteria

November 27, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Six months after completion of the test

IPD Sharing Access Criteria

IPD will be public accessable via Electronic Data Capture. (ResMan: http://www.medresman.org.)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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