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

NCT ID: NCT03968016

Last Updated: 2019-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-27

Study Completion Date

2019-05-10

Brief Summary

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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

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Conditions

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Diagnoses Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Healthy

Control group

Group Type PLACEBO_COMPARATOR

SYSMEX HLSCL

Intervention Type DEVICE

Diagnostic device

Stable heart disease

Stable heart disease and non-hospitalized

Group Type ACTIVE_COMPARATOR

SYSMEX HLSCL

Intervention Type DEVICE

Diagnostic device

Interventions

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SYSMEX HLSCL

Diagnostic device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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


* Aged \> 40 - 70 years
* Stable heart disease individuals will be evaluated by cardiologist
* Non hospitalized (OPD settings)

Exclusion Criteria

* Heart diseases
* Renal diseases (CKD or recent AKI)
* History of pulmonary embolism

For Patient group with stable heart diseases


* Stable heart diseases with ACS
* Renal diseases (CKD or recent AKI)
* History of pulmonary embolism
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chulalongkorn University

Pathum Wan, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Troponin T

Identifier Type: -

Identifier Source: org_study_id

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