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Rapid Identification of MINOCA Based on Novel Biomarkers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04974320
Recruitment Status : Enrolling by invitation
First Posted : July 23, 2021
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Jiali Wang, Qilu Hospital of Shandong University

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Myocardial Infarction With Non-obstructive Coronary Arteries Grow Stimulation Expressed Gene 2 Copeptin Identification Prognosis Biological: blood biomarkers

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 Design
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Study Type : Observational
Estimated Enrollment : 2616 participants
Observational Model: Other
Time Perspective: Retrospective
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
Actual Study Start Date : June 5, 2021
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Groups and Cohorts
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Group/Cohort Intervention/treatment
MINOCA
All patients diagnosed with MINOCA in precision cohort (NCT04044066) will be included.
 Biological: blood biomarkers
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.
 Biological: blood biomarkers
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.
 Biological: blood biomarkers
All patients were obtained blood biomarkers: troponin, ST2, copeptin
MINOCA （multi-center）
The patients diagnosed with MINOCA in multi-center cohort will be included.
 Biological: blood biomarkers
All patients were obtained blood biomarkers: troponin, ST2, copeptin


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Major Adverse Cardiac Events [ Time Frame: 12 months ]
    a composite of all-cause death, cardiac death, non-cardiac death, myocardial infarction or stroke


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients diagnosed with MINOCA and acute myocardial infarction（AMI）in BIpass that meet the inclusion and exclusion criteria of this project will be included, and patients with unstable angina（UA）in BIpass that meet the inclusion and exclusion criteria of this project will be selected according to the matching method. This project will include multi-center MINOCA patients for external validation of the model.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04974320


Locations
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China, Shandong
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Qilu Hospital of Shandong University
Investigators
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Principal Investigator: Jiali Wang, PhD,MD Qilu Hospital, Shandong University
More Information
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Responsible Party: Jiali Wang, deputy chief physician, Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT04974320    
Other Study ID Numbers: MINOCA QiluH
First Posted: July 23, 2021    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myocardial Infarction
MINOCA
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases