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

Not Applicable

Completed

• Conditions: Diagnoses Disease

• Registration Number: NCT03968016
• Lead Sponsor: Chulalongkorn University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-27
• Primary Completion: 2019-04-30
• Status Verified: 2019-05
• Study First Submitted: 2019-05-09
• Study Completion: 2019-05-10
• Study First Submitted QC: 2019-05-27
• Last Update Submitted: 2019-05-27
• Study First Posted: 2019-05-30
• Last Update Posted: 2019-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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)

Exclusion Criteria:

• Stable heart diseases with ACS
• Renal diseases (CKD or recent AKI)
• History of pulmonary embolism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Measurement of high sensitivity-troponin T level	3 days

Trial Locations

Locations (1)

Chulalongkorn University; 🇹🇭 Pathum Wan, Bangkok, Thailand