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

NCT ID: NCT06059079

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

80000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myocardial Infarction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Elevated hs-cTnT group

No Intervention

Intervention Type OTHER

No Intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No Intervention

No Intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chunjian Li

Director of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 25830423 (View on PubMed)

Benjamin EJ, Muntner P, Alonso A, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Das SR, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Jordan LC, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, O'Flaherty M, Pandey A, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Spartano NL, Stokes A, Tirschwell DL, Tsao CW, Turakhia MP, VanWagner LB, Wilkins JT, Wong SS, Virani SS; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association. Circulation. 2019 Mar 5;139(10):e56-e528. doi: 10.1161/CIR.0000000000000659. No abstract available.

Reference Type BACKGROUND
PMID: 30700139 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35535607 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30153967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36318533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34195803 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34167318 (View on PubMed)

Collet JP, Thiele H, Barbato E, Barthelemy O, Bauersachs J, Bhatt DL, Dendale P, Dorobantu M, Edvardsen T, Folliguet T, Gale CP, Gilard M, Jobs A, Juni P, Lambrinou E, Lewis BS, Mehilli J, Meliga E, Merkely B, Mueller C, Roffi M, Rutten FH, Sibbing D, Siontis GCM; ESC Scientific Document Group. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021 Apr 7;42(14):1289-1367. doi: 10.1093/eurheartj/ehaa575. No abstract available.

Reference Type BACKGROUND
PMID: 32860058 (View on PubMed)

China Society of Cardiology of Chinese Medical Association; Editorial Board of Chinese Journal of Cardiology. [Guideline for diagnosis and treatment of patients with ST-elevation myocardial infarction]. Zhonghua Xin Xue Guan Bing Za Zhi. 2010 Aug;38(8):675-90. No abstract available. Chinese.

Reference Type BACKGROUND
PMID: 21055132 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.