Rapid Identification of MINOCA Based on Novel Biomarkers
Applying Novel Biomarkers to Identify MINOCA Rapidly and the Prognostic Value of Novel Biomarkers Among Patients With Acute Chest Pain: a Clinical Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Shandong
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Jinan, Shandong, China, 250012
- Qilu Hospital of Shandong University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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MINOCA
All patients diagnosed with MINOCA in precision cohort (NCT04044066) will be included.
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All patients were obtained blood biomarkers: troponin, ST2, copeptin
|
|
acute myocardial infarction (AMI）
All patients diagnosed with acute myocardial infarction（AMI）in precision cohort (NCT04044066) will be included.
|
All patients were obtained blood biomarkers: troponin, ST2, copeptin
|
|
unstable angina (UA)
The patients diagnosed with unstable angina（UA) in precision cohort (NCT04044066) will be selected according to the matching method.
|
All patients were obtained blood biomarkers: troponin, ST2, copeptin
|
|
MINOCA （multi-center）
The patients diagnosed with MINOCA in multi-center cohort will be included.
|
All patients were obtained blood biomarkers: troponin, ST2, copeptin
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MINOCA
Time Frame: 12 months
|
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.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Major Adverse Cardiac Events
Time Frame: 12 months
|
a composite of all-cause death, cardiac death, non-cardiac death, myocardial infarction or stroke
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jiali Wang, PhD,MD, Qilu Hospital，Shandong University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MINOCA QiluH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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