Diagnoses DiseaseNCT03968016
Reference Interval Validation of High-Sensitivity Cardiac Troponin T Assay in Thai Population
A study testing SYSMEX HLSCL in people with Diagnoses Disease, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The investigators aimed to study the cut-off of high sensitivity troponin T using SYSMEX HLSCL Machine in Thai population at percentile 99. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnoses Disease
- What is being tested?
- SYSMEX HLSCL
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 27 Jan 2019to 10 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aimed to study the cut-off of high sensitivity troponin T using SYSMEX HLSCL Machine in Thai population at percentile 99.
- Conditions
- Diagnoses Disease
- Being tested
- SYSMEX HLSCL
- Keywords
- Acute Myocardial Infarction, Cardiac marker, Troponin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYSMEX HLSCLDevice
Diagnostic device
| Study group | Role | What they receive |
|---|---|---|
| Healthy | Placebo comparator | Control group Receives: Device: SYSMEX HLSCL |
| Stable heart disease | Active comparator | Stable heart disease and non-hospitalized Receives: Device: SYSMEX HLSCL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of high sensitivity-troponin T level
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start27 Jan 2019
- Primary completion30 Apr 2019
- Study completion10 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnoses DiseaseStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03968016
- Sponsor's protocol ID
- Troponin T
- Status last verified
- May 2019
- First submitted
- 9 May 2019
- Last updated
- 30 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Interval Validation of High-Sensitivity Cardiac Troponin T Assay in Thai Population
- ClinicalTrials.gov ID
- NCT03968016
- Acronym / sponsor ID
- Troponin T
- Conditions
- Diagnoses Disease
- Keywords
- Acute Myocardial Infarction, Cardiac marker, Troponin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 27 Jan 2019 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 10 May 2019 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aimed to study the cut-off of high sensitivity troponin T using SYSMEX HLSCL Machine in Thai population at percentile 99.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy | Placebo comparator | Device: SYSMEX HLSCLControl group |
| Stable heart disease | Active comparator | Device: SYSMEX HLSCLStable heart disease and non-hospitalized |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Heart diseases
- Renal diseases (CKD or recent AKI)
- History of pulmonary embolism
- For Patient group with stable heart diseases
- Stable heart diseases with ACS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYSMEX HLSCLDiagnostic device | Device | Healthy, Stable heart disease |
Primary outcome
Measurement of high sensitivity-troponin T level
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SYSMEX HLSCL in people with Diagnoses Disease, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of high sensitivity-troponin T level (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.