Myocardial Infarction With Non-obstructive Coronary ArteriesNCT04974320
Rapid Identification of MINOCA Based on Novel Biomarkers
An observational study of Myocardial Infarction With Non-obstructive Coronary Arteries and Grow Stimulation Expressed Gene 2, run by Qilu Hospital of Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction With Non-obstructive Coronary Arteries, Grow Stimulation Expressed Gene 2, Copeptin
- What is being tested?
- blood biomarkers
- How many people
- 2,616 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2021to Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Myocardial Infarction With Non-obstructive Coronary Arteries, Grow Stimulation Expressed Gene 2, Copeptin, Identification, Prognosis
- Being tested
- blood biomarkers
- Medical subject headings
- MINOCA, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood biomarkersBiological
All patients were obtained blood biomarkers: troponin, ST2, copeptin
| Study group | Role | What they receive |
|---|---|---|
| MINOCA | All patients diagnosed with MINOCA in precision cohort (NCT04044066) will be included. Receives: Biological: blood biomarkers | |
| acute myocardial infarction (AMI） | All patients diagnosed with acute myocardial infarction（AMI）in precision cohort (NCT04044066) will be included. Receives: 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. Receives: Biological: blood biomarkers | |
| MINOCA （multi-center） | The patients diagnosed with MINOCA in multi-center cohort will be included. Receives: Biological: blood biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
Major Adverse Cardiac Events
a composite of all-cause death, cardiac death, non-cardiac death, myocardial infarction or stroke
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start5 Jun 2021
- Primary completionAug 2024 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction With Non-obstructive Coronary ArteriesStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,616 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiali Wang, Qilu Hospital of Shandong University
- Investigators
- Jiali Wang, PhD,MD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974320
- Sponsor's protocol ID
- MINOCA QiluH
- Status last verified
- Jul 2021
- First submitted
- 12 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04974320
- Acronym / sponsor ID
- MINOCA QiluH
- Conditions
- Myocardial Infarction With Non-obstructive Coronary Arteries, Grow Stimulation Expressed Gene 2, Copeptin, Identification, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,616 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 5 Jun 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MINOCA | – | Biological: blood biomarkersAll patients diagnosed with MINOCA in precision cohort (NCT04044066) will be included. |
| acute myocardial infarction (AMI） | – | Biological: blood biomarkersAll patients diagnosed with acute myocardial infarction（AMI）in precision cohort (NCT04044066) will be included. |
| unstable angina (UA) | – | Biological: blood biomarkersThe patients diagnosed with unstable angina（UA) in precision cohort (NCT04044066) will be selected according to the matching method. |
| MINOCA （multi-center） | – | Biological: blood biomarkersThe patients diagnosed with MINOCA in multi-center cohort will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood biomarkersAll patients were obtained blood biomarkers: troponin, ST2, copeptin | Biological | MINOCA, MINOCA （multi-center）, acute myocardial infarction (AMI）, unstable angina (UA) |
Primary outcome
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.
1 secondary outcome
Major Adverse Cardiac Events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Myocardial Infarction With Non-obstructive Coronary Arteries
RecruitingObservational study
Coronary Microvascular Dysfunction Assessments in Myocardial Infarction With Non-Obstructive Coronary Arteries
Myocardial Infarction, Coronary Microvascular Dysfunction
RecruitingPhase 2
Stratified Medicine of Eplerenone in Acute Myocardial Infarction or Injury and no Obstructive Coronary Arteries.
Myocardial Infarction, Acute, Myocardial Infarction With Nonobstructive Coronary Arteries
RecruitingObservational study
Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation
Acute Coronary Syndrome, Myocardium; Injury
RecruitingObservational study
Barts-MINOCA Registry
Myocardial Infarction, Gender
Active, not recruitingObservational study
Starring Optical Coherence Tomography During Percutaneous Coronary Intervention Guidance
Acute Coronary Syndromes (ACS), Chronic Coronary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiali Wang, PhD,MD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction With Non-obstructive Coronary Arteries and Grow Stimulation Expressed Gene 2, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MINOCA (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.