Establishment and Evaluation of Mindray Cardiac Troponin Fragmentation Assay Combination for Rapid Diagnosis of non-ST-segment elevation myocardial infarction

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400087372

Enrollment

Unknown

Registered

2024-07-25

Start date

2024-07-26

Completion date

Unknown

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myocardial infarction without ST elevation

Interventions

Training set - Negative group:Confirmed to have NOT experienced acute non-ST-segment elevation myocardial infarction

Training set - Positive group:Confirmed to have experienced acute non-ST-segment elevation myocardial infarction

Validation set - Negative group:Confirmed to have NOT experienced acute non-ST-segment elevation myocardial infarction

Validation set - Positive group:Confirmed to have experienced acute non-ST-segment elevation myocardial infarction

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1: age = 18 years 2: Presented due to suspected symptoms or signs of acute myocardial infarction (Possible cardiac symptoms include: acute chest, upper abdominal, neck, jaw, or arm pain, discomfort, or pressure) 3: The first blood sample will be collected upon presentation, and the second blood sample will be collected 1 to 3 hours after presentation 4: Record at least one 12-lead electrocardiogram (ECG) 5: Record the results of Roche hs-cTnT testing

Exclusion criteria

Exclusion criteria: 1: Admitted with confirmed ST-segment elevation myocardial infarction 2: Patients who have undergone major surgery or suffered severe trauma within the past month 3: Pregnancy 4: Patients who experienced cardiac arrest/cardiogenic shock prior to admission 5: Patients with missing laboratory test information or critical clinical and medical history information 6: Transferred from another hospital 7: The researcher judged that the individual is unsuitable for participation due to other reasons

Design outcomes

Primary

Measure	Time frame
All-cause mortality, recurrent acute myocardial infarction, and revascularization therapy (coronary);	—

Secondary

Measure	Time frame
Death due to heart disease, readmission for cardiac issues, stroke;	—

Countries

China

Contacts

Public ContactJunbo Ge

Zhongshan Hospital, Fudan University

ge.junbo@zs-hospital.sh.cn+86 139 0197 7506

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026