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Prospective Multicenter Study for Early Evaluation of Acute Chest Pain

Prospective Multicenter Study for Early Evaluation of Acute Chest Pain

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04122573
Acronym
PEACP
Enrollment
10000
Registered
2019-10-10
Start date
2019-11-01
Completion date
2022-10-31
Last updated
2019-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

DIAGNOSTIC_TESTCoronary angiography

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

DIAGNOSTIC_TESTCT angiography of aorta

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

DIAGNOSTIC_TESTCT angiography of pulmonary arteries.

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

DIAGNOSTIC_TESTElectrocardiogram

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.

DIAGNOSTIC_TESTCardiac Troponin

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

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of participants with acute aortic dissectionTwenty-four hoursChest pain patients are diagnosed as acute aortic dissection based on CT of aortic angiography.
Rate of participants with acute coronary syndromeTwenty-four hoursChest pain patients are diagnosed as acute coronary syndrome based on European Society of Cardiology (ESC) guidelines.
Rate of participants with all-cause deathOne yearPatients die of all causes during hospitalization or follow-up
Rate of participants with cardiovascular deathOne yearPatients die of cardiac and cerebrovascular diseases during hospitalization or follow-up
Rate of participants with major adverse cardiac events (MACEs)One yearMACEs include cardiac death, stroke, and recurrent myocardial infarction.
Rate of participants with acute myocardial infarctionTwenty-four hoursChest pain patients are diagnosed as acute myocardial infarction based on fourth edition of guidelines for myocardial infarction
Rate of participants with acute pulmonary embolismTwenty-four hoursChest pain patients are diagnosed as acute pulmonary embolism based on CT of pulmonary angiography.

Secondary

MeasureTime frameDescription
Rate of participants with malignant arrhythmiaTwo weeksPatients complicate with malignant arrhythmia during hospitalization
Rate of participants with pericardial tamponadeTwo weeksPatients complicate with pericardial tamponade during hospitalization
Rate of participants with multiple organ dysfunction syndromeTwo weeksPatients complicate with multiple organ dysfunction syndrome during hospitalization
Rate of participants with respiratory failureTwo weeksPatients complicate with respiratory failure during hospitalization
Rate of participants with cardiac arrestTwo weeksThe 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.
Rate of participants with bleedingOne yearPatients complicate with bleeding
Rate of participants with acute kidney injuryTwo weeksPatients complicate with acute kidney injury during hospitalization
Rate of participants with revascularizationTwo weeksPatients receive revascularization for recurrent angina or myocardial infarction during hospitalization
Rate of participants with consciousness disorderTwo weeksPatients complicate with consciousness disorder during hospitalization
Rate of participants with cardiogenic shockTwo weeksPatients complicate with cardiogenic shock during hospitalization
Rate of participants with ischemia or necrosis of lower limbsTwo weeksPatients complicate with ischemia or necrosis of lower limbs during hospitalization
Rate of participants with acute heart failureTwo weeksPatients complicate with acute heart failure during hospitalization

Other

MeasureTime frameDescription
Length of stayTwo weeksTime between patient's visit and discharge
Rate of re-admitted participantsSix monthsRe-admission after discharge within 6 months

Countries

China

Contacts

Primary ContactDongze Li, MBBS
dongze.li@ymail.com+86-28-85422461
Backup ContactYisong Cheng, MBBS
yisongcheng01@163.com+86-19983154487

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026