Using Higher Cut-off Values to Diagnose Acute Myocardial Infarction in Patients With Elevated Hs-cTnT Concentrations

Acute Myocardial Infarction Clinical Trial

Official title:

Using Higher Cut-off Values to Diagnose Acute Myocardial Infarction in Patients With Elevated Hs-cTnT Concentrations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06059079
• Other study ID #: 023
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2023
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

High-sensitive cardiac troponin T (hs-cTnT) is a cornerstone for diagnosing acute myocardial infarction (AMI). However, it is often challenging to diagnose AMI in patients with elevated hs-cTnT before a rise or fall of hs-cTnT can be observed. The elevations of hs-cTnT are caused not only by AMI, but also by other cardiac or even non-cardiac diseases. Thresholds above the 99th percentile have been proposed to improve the specificity and to accelerate the rule in of myocardial infarction. This study aimed to find a more accurate cut-off value to rule in AMI in patients with elevated hs-cTnT.

Description:

Acute myocardial infarction (AMI) is a major cause of morbidity and mortality worldwide. In real clinical practice, early and accurate recognition of AMI is crucial to accelerate effective reperfusion therapy. High-sensitivity cardiac troponin T (hs-cTnT) is an important protein that regulates cardiomyocytes excitability, which can be proliferated in cardiomyocytes and released into the blood after myocardial injury or infarction. According to the fourth universal definition of AMI, a rise and/or fall of cTn values with at least one value above the 99th percentile URL is the essential precondition for diagnosing AMI. However, it is challenging for clinicians to diagnose AMI in patients with elevated hs-cTnT levels before a rise and/or fall of hs-cTnT values can be observed, particularly for those who present atypical symptoms and non-significant changes in electrocardiograms (ECG). When the 99th percentile upper reference limit (URL) is referred, it happens frequently that the elevations of hs-cTnT are not caused by AMI, but by other cardiac or even non-cardiac diseases. Therefore, thresholds above the 99th percentile have been proposed to improve the specificity and to accelerate the rule in of myocardial infarction.

This study aimed to find a higher and more accurate cut-off value of hs-cTnT to rule in AMI in a large volume of patients with elevated hs-cTnT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80000
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients hospitalized from January 1,2015 to May 31,2023 in the First Affiliated Hospital of Nanjing Medical University with hs-cTnT concentrations over 14.0 ng/L were enrolled.

Exclusion Criteria:

• Patients who underwent major cardiac surgeries during the hospitalization.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Other:
• No Intervention
No Intervention

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (9)

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Eggers KM, Hammarsten O, Aldous SJ, Cullen L, Greenslade JH, Lindahl B, Parsonage WA, Pemberton CJ, Pickering JW, Richards AM, Troughton RW, Than MP. Diagnostic and prognostic performance of the ratio between high-sensitivity cardiac troponin I and troponin T in patients with chest pain. PLoS One. 2022 Nov 1;17(11):e0276645. doi: 10.1371/journal.pone.0276645. eCollection 2022. — View Citation

Nestelberger T, Boeddinghaus J, Gimenez MR, Lopez-Ayala P, Ratmann PD, Badertscher P, Wildi K, Wussler D, Koechlin L, Arslani K, Zimmermann T, Freese M, Rinderknecht T, Miro O, Martin-Sanchez FJ, Kawecki D, Geigy N, Keller D, Twerenbold R, Muller C; APACE investigators. Direct comparison of high-sensitivity cardiac troponin T and I in the early differentiation of type 1 vs. type 2 myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2022 Jan 12;11(1):62-74. doi: 10.1093/ehjacc/zuab039. — View Citation

Roth GA, Forouzanfar MH, Moran AE, Barber R, Nguyen G, Feigin VL, Naghavi M, Mensah GA, Murray CJ. Demographic and epidemiologic drivers of global cardiovascular mortality. N Engl J Med. 2015 Apr 2;372(14):1333-41. doi: 10.1056/NEJMoa1406656. — View Citation

Sandoval Y, Lewis BR, Mehta RA, Ola O, Knott JD, De Michieli L, Akula A, Lobo R, Yang EH, Gharacholou SM, Dworak M, Crockford E, Rastas N, Grube E, Karturi S, Wohlrab S, Hodge DO, Tak T, Cagin C, Gulati R, Jaffe AS. Rapid Exclusion of Acute Myocardial Injury and Infarction With a Single High-Sensitivity Cardiac Troponin T in the Emergency Department: A Multicenter United States Evaluation. Circulation. 2022 Jun 7;145(23):1708-1719. doi: 10.1161/CIRCULATIONAHA.122.059235. Epub 2022 May 10. — View Citation

Thygesen K, Alpert JS, Jaffe AS, Chaitman BR, Bax JJ, Morrow DA, White HD; Executive Group on behalf of the Joint European Society of Cardiology (ESC)/American College of Cardiology (ACC)/American Heart Association (AHA)/World Heart Federation (WHF) Task Force for the Universal Definition of Myocardial Infarction. Fourth Universal Definition of Myocardial Infarction (2018). J Am Coll Cardiol. 2018 Oct 30;72(18):2231-2264. doi: 10.1016/j.jacc.2018.08.1038. Epub 2018 Aug 25. No abstract available. — View Citation

Wereski R, Kimenai DM, Taggart C, Doudesis D, Lee KK, Lowry MTH, Bularga A, Lowe DJ, Fujisawa T, Apple FS, Collinson PO, Anand A, Chapman AR, Mills NL. Cardiac Troponin Thresholds and Kinetics to Differentiate Myocardial Injury and Myocardial Infarction. Circulation. 2021 Aug 17;144(7):528-538. doi: 10.1161/CIRCULATIONAHA.121.054302. Epub 2021 Jun 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients diagnosed with acute myocardial infarction		Within 3 days of experiencing chest pain, electrocardiogram changes, or abnormal hs-cTnT values.