Reference Interval Validation of High-Sensitivity Cardiac... | NCT03968016

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

NCT03968016

Sponsor

Chulalongkorn University

Status

Completed

Last Update Posted

May 30, 2019Actual

Enrollment

120Actual

Phase

Not Applicable

Conditions

Diagnoses Disease

Interventions

SYSMEX HLSCL

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 27, 2019Actual

Primary Completion Date

Apr 30, 2019Actual

Completion Date

May 10, 2019Actual

First Submitted Date

May 9, 2019

First Submission Date that Met QC Criteria

May 27, 2019

First Posted Date

May 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2019

Last Update Posted Date

May 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Healthy	Placebo Comparator	Control group	Device: SYSMEX HLSCL
Stable heart disease	Active Comparator	Stable heart disease and non-hospitalized	Device: SYSMEX HLSCL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SYSMEX HLSCL	Device	Diagnostic device	Healthy Stable heart disease

Measure	Description	Time Frame
Measurement of high sensitivity-troponin T level		3 days

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chulalongkorn University		Pathum Wan	Bangkok	10330	Thailand