Clinical trial NCT05665127: Point of Care Evaluation of High-sensitivity Cardiac Troponin
Official title: Point of Care Evaluation of High-sensitivity Cardiac Troponin
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Coronary Syndrome
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: NHS Grampian
name: Siemens Healthcare Diagnostics Ltd
First posted: 2022-12-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected acute coronary syndrome attending the Emergency Department or Acute Medical Unit

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.


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

Primary outcomes:
measure: Type 1, 4b or 4c myocardial infarction or cardiac death
timeFrame: Index presentation to 30 days
Secondary outcomes:
measure: Any myocardial infarction
timeFrame: Index presentation to 1 year
measure: Cardiac death
timeFrame: Index presentation to 1 year
measure: Any myocardial infarction or cardiac death
timeFrame: Index presentation to 1 year
measure: Cardiovascular death
timeFrame: Index presentation to 1 year
measure: All-cause death
timeFrame: Index presentation to 1 year
measure: Reattendance with suspected acute coronary syndrome
timeFrame: Index presentation to 1 year
measure: Unplanned coronary revascularization
timeFrame: Following index presentation to 1 year
Other outcomes:
measure: Time from presentation to rule-out or rule-in myocardial infarction
timeFrame: 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)
measure: Duration of stay in hospital (index)
timeFrame: Time from index presentation until the time of discharge from hospital, assessed up to the end of study follow up (12 months)
measure: Duration of stay in Emergency Department
timeFrame: Time from index presentation until the time of discharge from the Emergency Department, assessed up to the end of study follow up (12 months)
measure: Inter-assay coefficient of variation
timeFrame: During index admission, assessed up to 36 hours following enrolment
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
Study officials:
affiliation: University of Edinburgh
name: Nicholas Mills
role: PRINCIPAL_INVESTIGATOR
References: