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

Chulalongkorn University

Status: Completed

Conditions: Diagnoses Disease

Treatments: Device: SYSMEX HLSCL

Study type: Interventional

Funder types: Other

Identifiers

NCT03968016

Troponin T

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Exclusion Criteria:

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

Healthy

Placebo Comparator group

Description:

Control group

Treatment:

Device: SYSMEX HLSCL

Stable heart disease

Active Comparator group

Description:

Stable heart disease and non-hospitalized

Treatment:

Device: SYSMEX HLSCL