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

Diagnoses Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968016
• Other study ID #: Troponin T
• Status: Completed
• Phase: N/A
• Start date: January 27, 2019
• Est. completion date: May 10, 2019

Study information

• Verified date: May 2019
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 10, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Exclusion Criteria:

• Stable heart diseases with ACS

• Renal diseases (CKD or recent AKI)

• History of pulmonary embolism

Related Conditions & MeSH terms

• Diagnoses Disease

Intervention

Device:
• SYSMEX HLSCL
Diagnostic device

Locations

Country	Name	City	State
Thailand	Chulalongkorn University	Pathum Wan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of high sensitivity-troponin T level		3 days