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

Primary Purpose

Diagnoses Disease

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
SYSMEX HLSCL
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diagnoses Disease focused on measuring Acute Myocardial Infarction, Cardiac marker, Troponin

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chulalongkorn University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Healthy

Stable heart disease

Arm Description

Control group

Stable heart disease and non-hospitalized

Outcomes

Primary Outcome Measures

Measurement of high sensitivity-troponin T level

Secondary Outcome Measures

Full Information

First Posted
May 9, 2019
Last Updated
May 27, 2019
Sponsor
Chulalongkorn University
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1. Study Identification

Unique Protocol Identification Number
NCT03968016
Brief Title
Reference Interval Validation of High-Sensitivity Cardiac Troponin T Assay in Thai Population
Official Title
Reference Interval Validation of High-Sensitivity Cardiac Troponin T Assay in Thai Population
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 27, 2019 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
May 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chulalongkorn University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diagnoses Disease
Keywords
Acute Myocardial Infarction, Cardiac marker, Troponin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy
Arm Type
Placebo Comparator
Arm Description
Control group
Arm Title
Stable heart disease
Arm Type
Active Comparator
Arm Description
Stable heart disease and non-hospitalized
Intervention Type
Device
Intervention Name(s)
SYSMEX HLSCL
Intervention Description
Diagnostic device
Primary Outcome Measure Information:
Title
Measurement of high sensitivity-troponin T level
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Chulalongkorn University
City
Pathum Wan
State/Province
Bangkok
ZIP/Postal Code
10330
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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