Reference Interval Validation of High-Sensitivity Cardiac Troponin T Assay in Thai Population

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03968016

Enrollment

120

Registered

2019-05-30

Start date

2019-01-27

Completion date

2019-05-10

Last updated

2019-05-30

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

Conditions

Diagnoses Disease

Keywords

Acute Myocardial Infarction, Cardiac marker, Troponin

Brief summary

The investigators aimed to study the cut-off of high sensitivity troponin T using SYSMEX HLSCL Machine in Thai population at percentile 99.

Interventions

DEVICESYSMEX HLSCL

Diagnostic device

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

For healthy group Inclusion Criteria: * Group 1: Aged 18 - 40 years * Group 2: Aged \> 40 - 70 years * A presumably healthy population will define from a health questionnaire

Exclusion criteria

* Heart diseases * Renal diseases (CKD or recent AKI) * History of pulmonary embolism For Patient group with stable heart diseases Inclusion Criteria: * Aged \> 40 - 70 years * Stable heart disease individuals will be evaluated by cardiologist * Non hospitalized (OPD settings)

Design outcomes

Primary

Measure	Time frame
Measurement of high sensitivity-troponin T level	3 days

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026