Rapid Identification of MINOCA Based on Novel Biomarkers

Prognosis Clinical Trial

Official title:

Applying Novel Biomarkers to Identify MINOCA Rapidly and the Prognostic Value of Novel Biomarkers Among Patients With Acute Chest Pain: a Clinical Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04974320
• Other study ID #: MINOCA QiluH
• Status: Enrolling by invitation
• Start date: June 5, 2021
• Est. completion date: August 2024

Study information

• Verified date: July 2021
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Among the patients diagnosed as acute myocardial infarction by coronary angiography, 5%-25% of the patients did not find coronary artery obstructive lesions. These patients do not need PCI. The discovery and verification of clinical protocols for accurate identification of myocardial infarction in the absence of obstructive coronary artery disease（MINOCA）is a major issue that needs to be addressed.Novel biomarkers like grow stimulation expressed gene 2（ST2）can indicate the degree of coronary artery obstruction, copeptin is a biomarker of cardiac emergency state. No clinical studies have been conducted to evaluate whether the novel biomarkers combination regimen can diagnose or exclude MINOCA.

Our research aims to establish and validate a model for the recognition of MINOCA based on novel biomarkers (ST2, copeptin) and to evaluate the prognostic value of novel biomarkers among patients with acute chest pain.

Description:

A cross-sectional study design will be used to evaluate the correlation between baseline novel biomarkers（ST2 and copeptin）and MINOCA, and to establish a discriminant model for the identification of MINOCA, and to verify its discriminant efficacy. A cohort study design will be used to evaluate the prognostic role of novel biomarkers in patients with acute chest pain.

On the basis of precision cohort (BIPASS), the project team will adopt the method of cross-sectional diagnostic experimental study design. ①Blood samples of MINOCA and AMI were extracted. According to the new biomarkers（ST2 and copeptin）reported in literature, the team will detect and combine them with troponin, and correct the covariate. And then establish the multivariate joint discriminant model. ②At the same time, according to the propensity score, patients will be selected from UA in a 1:1 matching ratio for modeling. The discriminant model for rapid recognition of MINOCA will be verified by internal cross validation and external validation. Based on this discriminant model, whether the combined application of three biomarkers in MINOCA diagnosis is superior to that of a single biomarker will also be evaluated. Patients with acute chest pain from multi-center will be selected to verify the accuracy of the rapid discriminant model of MINOCA applied to patients with acute chest pain.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2616
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The clear diagnosis of MINOCA, acute myocardial infarction(AMI) and unstable angina(UA) in BIpass

• The clear diagnosis of MINOCA from the multi-center cohort

Exclusion Criteria:

• Prior surgery (cardiac or non-cardiac), trauma or clinically evident coagulopathic bleeding (e.g. gastrointestinal, genitourinary, et al)

• Patient with non-cardiac co-morbidities with life expectancy less than 12 months

• Patients unwilling or unable to comply with all clinical follow-up schedules

Related Conditions & MeSH terms

• Copeptin
• Infarction
• Myocardial Infarction
• Myocardial Infarction With Non-obstructive Coronary Arteries
• Prognosis

Intervention

Biological:
• blood biomarkers
All patients were obtained blood biomarkers: troponin, ST2, copeptin

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MINOCA	The diagnosis of MINOCA is made immediately upon coronary angiography in a patient presenting with features consistent with an AMI, as detailed by the following criteria: universal AMI criteria; non-obstructive coronary arteries on angiography, defined as no coronary artery stenosis ?50% in any potential IRA; no clinically overt specific cause for the acute presentation.	12 months
Secondary	Major Adverse Cardiac Events	a composite of all-cause death, cardiac death, non-cardiac death, myocardial infarction or stroke	12 months