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

Sponsor
The First Affiliated Hospital with Nanjing Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT06059079
Collaborator
(none)
80,000
1
100.9
792.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No Intervention

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
80000 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Using Higher Cut-off Values to Diagnose Acute Myocardial Infarction in Patients With Elevated Hs-cTnT Concentrations
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
May 31, 2023
Actual Study Completion Date :
May 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Elevated hs-cTnT group

Other: No Intervention
No Intervention

Outcome Measures

Primary Outcome Measures

  1. Number of patients diagnosed with acute myocardial infarction [Within 3 days of experiencing chest pain, electrocardiogram changes, or abnormal hs-cTnT values.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210029

Sponsors and Collaborators

  • The First Affiliated Hospital with Nanjing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Chunjian Li, Director of Cardiology, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT06059079
Other Study ID Numbers:
  • 023
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chunjian Li, Director of Cardiology, The First Affiliated Hospital with Nanjing Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2023