NCT06059079

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2015

Completed
8.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

8.4 years

First QC Date

September 20, 2023

Last Update Submit

September 26, 2023

Conditions

Keywords

Acute Myocardial InfarctionHigh sensitivity cardiac troponin TRule in

Outcome Measures

Primary Outcomes (1)

  • Number of patients diagnosed with acute myocardial infarction

    Within 3 days of experiencing chest pain, electrocardiogram changes, or abnormal hs-cTnT values.

Study Arms (1)

Elevated hs-cTnT group

Other: No Intervention

Interventions

No Intervention

Elevated hs-cTnT group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients' data were obtained from hospital's Clinical Data Repository (CDR), which integrates patients' baseline characteristics, laboratory results, clinical diagnosis, and treatment information during the index hospitalization. And all of the 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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who underwent major cardiac surgeries during the hospitalization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Related Publications (9)

  • 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.

    PMID: 25830423BACKGROUND
  • 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.

    PMID: 30700139BACKGROUND
  • 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.

    PMID: 35535607BACKGROUND
  • 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.

    PMID: 30153967BACKGROUND
  • 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.

    PMID: 36318533BACKGROUND
  • 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.

    PMID: 34195803BACKGROUND
  • 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.

    PMID: 34167318BACKGROUND
  • 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.

    PMID: 32860058BACKGROUND
  • 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.

    PMID: 21055132BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiology

Study Record Dates

First Submitted

September 20, 2023

First Posted

September 28, 2023

Study Start

January 1, 2015

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations