NCT04974320

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,616

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 12, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 23, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

July 23, 2021

Status Verified

July 1, 2021

Enrollment Period

3.2 years

First QC Date

July 12, 2021

Last Update Submit

July 21, 2021

Conditions

Myocardial Infarction With Non-obstructive Coronary ArteriesGrow Stimulation Expressed Gene 2CopeptinIdentificationPrognosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Major Adverse Cardiac Events

    12 months

Study Arms (4)

MINOCA

All patients diagnosed with MINOCA in precision cohort (NCT04044066) will be included.

Biological: blood biomarkers

acute myocardial infarction (AMI）

All patients diagnosed with acute myocardial infarction（AMI）in precision cohort (NCT04044066) will be included.

Biological: blood biomarkers

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

MINOCA （multi-center）

The patients diagnosed with MINOCA in multi-center cohort will be included.

Biological: blood biomarkers

Interventions

blood biomarkersBIOLOGICAL

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

MINOCAMINOCA （multi-center）acute myocardial infarction (AMI）unstable angina (UA)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

MINOCADiabetes Insipidus

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Study Officials

  • Jiali Wang, PhD,MD

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
deputy chief physician

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 23, 2021

Study Start

June 5, 2021

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

July 23, 2021

Record last verified: 2021-07

Locations

CN(1)