NCT03968016

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

May 9, 2019

Last Update Submit

May 27, 2019

Conditions

Diagnoses Disease

Keywords

Acute Myocardial InfarctionCardiac markerTroponin

Outcome Measures

Primary Outcomes (1)

  • Measurement of high sensitivity-troponin T level

    3 days

Study Arms (2)

Healthy

PLACEBO COMPARATOR

Control group

Device: SYSMEX HLSCL

Stable heart disease

ACTIVE COMPARATOR

Stable heart disease and non-hospitalized

Device: SYSMEX HLSCL

Interventions

SYSMEX HLSCLDEVICE

Diagnostic device

HealthyStable heart disease

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Heart diseases
  • Renal diseases (CKD or recent AKI)
  • History of pulmonary embolism
  • For Patient group with stable heart diseases
  • Aged \> 40 - 70 years
  • Stable heart disease individuals will be evaluated by cardiologist
  • Non hospitalized (OPD settings)
  • Stable heart diseases with ACS
  • Renal diseases (CKD or recent AKI)
  • History of pulmonary embolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chulalongkorn University

Pathum Wan, Bangkok, 10330, Thailand

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 30, 2019

Study Start

January 27, 2019

Primary Completion

April 30, 2019

Study Completion

May 10, 2019

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

TH(1)