Point of Care Evaluation of High-sensitivity Cardiac Trop... | NCT05665127

Studies
Point of Care Evaluation of High-sensitivity Cardiac Troponin

NCT05665127

Sponsor

University of Edinburgh

Status

Active, not recruiting

Last Update Posted

May 4, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Acute Coronary Syndrome

Interventions

Not provided

Countries

United Kingdom

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

ID	Type	Description	Link
RG/20/10/34966	Other Grant/Funding Number	British Heart Foundation

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 16, 2022Actual

Primary Completion Date

Feb 28, 2025Actual

Completion Date

Feb 28, 2027Estimated

First Submitted Date

Dec 6, 2022

First Submission Date that Met QC Criteria

Dec 16, 2022

First Posted Date

Dec 27, 2022Actual

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

Apr 28, 2026

Last Update Posted Date

May 4, 2026Actual

Name	Class
British Heart Foundation	OTHER
NHS Grampian	OTHER_GOV
Siemens Healthcare Diagnostics Ltd	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

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

In this observational research project the investigators wish to test new technologies that could allow them to either detect or rule out heart attacks earlier.

Currently, when a patient attends the Emergency Department with symptoms that could be due to a heart attack, the patient has a blood test taken from a vein in the arm. This is sent to a laboratory to measure the level of a protein called troponin that is released from the heart when it is damaged. Doctors and nurses use the level of troponin measured in that blood sample, along with a tracing of the heart and an assessment of symptoms, to decide whether the patient is having a heart attack. On average, it takes about 2 hours from the patient arriving at hospital to the doctor or nurse receiving the blood test result so they can make this diagnosis.

A device has been designed that can measure troponin by using a drop of blood from a finger prick with the result available in around 10 minutes. This means that if a patient is having a heart attack we can diagnose it earlier and give them treatment. Previous studies have also showed that the majority of patients who attend hospital with chest pain ultimately do not have a heart attack. With this new device the investigators hope to be able to reassure these patients that their symptoms are not due to a heart attack, so the clinical team can concentrate on finding out what else could be causing their chest pain, and ultimately discharge them earlier.

The investigators aim to find the best way to use this new device and look at the impact this device has on the length of time from sample to diagnosis and time spent in hospital.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Type 1, 4b or 4c myocardial infarction or cardiac death		Index presentation to 30 days

Secondary Outcomes

Measure	Description	Time Frame
Any myocardial infarction		Index presentation to 1 year
Cardiac death		Index presentation to 1 year
Any myocardial infarction or cardiac death

Other Outcomes

Measure	Description	Time Frame
Time from presentation to rule-out or rule-in myocardial infarction		Time of index presentation until the time of reporting of the troponin result that rules in or rules out myocardial infarction, assessed up to the end of study follow up (12 months)
Duration of stay in hospital (index)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Presenting to hospital with symptoms of suspected acute coronary syndrome
Age 18 years and over

Exclusion Criteria:

Patients with ST-segment elevation on the electrocardiogram
Patients presenting with an out-of-hospital cardiac arrest
Patients unable or unwilling to give informed consent
Patients unable or unwilling to comply with study protocol
Previous enrolment in this study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with suspected acute coronary syndrome attending the Emergency Department or Acute Medical Unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicholas Mills	University of Edinburgh	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NHS Lothian		Edinburgh			United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

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Browse Branches

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