Rapid Identification of MINOCA Based on Novel Biomarkers

Sponsor
Qilu Hospital of Shandong University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04974320
Collaborator
(none)
2,616
Enrollment
1
Location
37.9
Anticipated Duration (Months)
69.1
Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Type:
Observational
Anticipated 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 :
Jun 5, 2021
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

ArmIntervention/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

Primary Outcome Measures

  1. MINOCA [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 [12 months]

    a composite of all-cause death, cardiac death, non-cardiac death, myocardial infarction or stroke

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

SiteCityStateCountryPostal Code
1Qilu Hospital of Shandong UniversityJinanShandongChina250012

Sponsors and Collaborators

  • Qilu Hospital of Shandong University

Investigators

  • Principal Investigator: Jiali Wang, PhD,MD, Qilu Hospital,Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiali Wang, deputy chief physician, Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier:
NCT04974320
Other Study ID Numbers:
  • MINOCA QiluH
First Posted:
Jul 23, 2021
Last Update Posted:
Jul 23, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 23, 2021