NCT04122573

Brief 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 methods. Risk stratification and short-term and long-term prognostic evaluation models for high-risk ACP will be established using large data analysis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

October 6, 2019

Last Update Submit

November 27, 2019

Conditions

Keywords

Chest painAcute Aortic DissectionPulmonary EmbolismAcute Coronary SyndromeAcute myocardial infarctionRisk stratificationPrognosisBiomarkers

Outcome Measures

Primary Outcomes (7)

  • Rate of participants with all-cause death

    Patients die of all causes during hospitalization or follow-up

    One year

  • Rate of participants with cardiovascular death

    Patients die of cardiac and cerebrovascular diseases during hospitalization or follow-up

    One year

  • Rate of participants with major adverse cardiac events (MACEs)

    MACEs include cardiac death, stroke, and recurrent myocardial infarction.

    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

    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.

    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.

    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.

    Twenty-four hours

Secondary Outcomes (12)

  • Rate of participants with ischemia or necrosis of lower limbs

    Two weeks

  • Rate of participants with acute heart failure

    Two weeks

  • Rate of participants with revascularization

    Two weeks

  • Rate of participants with consciousness disorder

    Two weeks

  • Rate of participants with cardiogenic shock

    Two weeks

  • +7 more secondary outcomes

Other Outcomes (2)

  • Length of stay

    Two weeks

  • Rate of re-admitted participants

    Six months

Study Arms (1)

Acute chest pain

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

Diagnostic Test: Coronary angiographyDiagnostic Test: CT angiography of aortaDiagnostic Test: CT angiography of pulmonary arteries.Diagnostic Test: ElectrocardiogramDiagnostic Test: Cardiac Troponin

Interventions

Coronary angiographyDIAGNOSTIC_TEST

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

Acute chest pain

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

Also known as: CTA
Acute chest pain

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

Also known as: CTA
Acute chest pain
ElectrocardiogramDIAGNOSTIC_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.

Also known as: ECG
Acute chest pain
Cardiac TroponinDIAGNOSTIC_TEST

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

Also known as: Biomarkers of myocardial injury
Acute chest pain

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patient aged 18-90 years old;
  • The time from onset of symptoms to emergency room is less than 24 hours.

You may not qualify if:

  • Patients complicate with end-stage neoplastic diseases;
  • Pregnant women;
  • Patients re-visit during the selection period;
  • Patients refuse to participate in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

RECRUITING

Chengdu Second People's Hospital

Chengdu, Sichuan, 610021, China

RECRUITING

Chengdu Shangjin Nanfu Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

Sichuan Integrative Medicine Hospital

Chengdu, Sichuan, 610041, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

People's Hospital of Xindu District

Chengdu, Sichuan, 610500, China

RECRUITING

Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646099, China

RECRUITING

Panzhihua Central Hospital

Panzhihua, Sichuan, 617000, China

RECRUITING

Zigong Fourth People's Hospital

Zigong, Sichuan, 643000, China

RECRUITING

Related Publications (1)

  • 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.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and plasma

MeSH Terms

Conditions

Chest PainPulmonary EmbolismAcute Coronary Syndrome

Interventions

Coronary AngiographyElectrocardiography

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesMyocardial IschemiaHeart Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyRadiographyDiagnostic Techniques, CardiovascularHeart Function TestsElectrodiagnosis

Study Officials

  • Dongze Li, MBBS

    Emergency Department, West China Hospital, Sichuan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yisong Cheng, MBBS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Clinical Research

Study Record Dates

First Submitted

October 6, 2019

First Posted

October 10, 2019

Study Start

November 1, 2019

Primary Completion

October 31, 2021

Study Completion

October 31, 2022

Last Updated

November 29, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Six months after completion of the test
Access Criteria
IPD will be public accessable via Electronic Data Capture. (ResMan: http://www.medresman.org.)
More information

Locations