Clinical trial NCT06325020: Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology
Official title: ORACLE: Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Angina, Stable
Coronary Artery Disease
Keywords: angina, chest pain, cardiac troponin, risk stratification
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients referred to the rapid access chest pain service within NHS Lothian will be eligible to participate in our feasibility study.

Brief summary: The ORACLE study is an observational cohort study designed to explore the feasibility of providing an assessment of chest pain for patients with suspected angina within one working day of referral to specialist services.

The primary objective is to determine the feasibility of delivering an objective assessment of risk for participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in a community setting using point of care and patient facing technologies within one working day of referral.

Participants will complete a digital health questionnaire, at home, that asks about their risk factors for coronary artery disease, past medical history and their symptoms.

Patients will then have a standard 12 lead ECG and perform their own personal ECG. They will then have high sensitivity cardiac troponin measured by point of care high sensitivity cardiac troponin assays as well as a core lab assay.

The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events.

Detailed description: Recent onset of angina is a clinical manifestation of unstable or progressive coronary artery disease and is a common presentation within primary care. Evaluation can be challenging as access to objective measures of risk and diagnostic testing are limited in this setting. Due to capacity, not all patients referred to the rapid access chest pain clinic can be reviewed within this clinic.

Patients are often high risk with suspected obstructive coronary artery disease, and the aim should be for review, assessment and if required, initiation of therapy, without undue delay.

This study has been designed to explore the feasibility of delivering a virtual chest pain assessment for patients with new onset chest pain. It is an observational cohort study, that uses a combination of digital tools to capture relevant patient information and clinical history, point-of-care high-sensitivity cardiac troponin testing and electrocardiography.

This pathway will aim to provide an objective assessment of risk on the next working day following primary care contact to all patients referred to the rapid access chest pain clinic.

On completion of this assessment patients will be stratified to low, intermediate or high risk groups based on their symptoms, risk factors, point of care troponin value (ng/l) and ECG. The results will not be made available to the clinical team unless the patients was at risk of harm (acute coronary syndrome or arrhythmia). Patients will return to receive routine clinical care.

The investigators plan to recruit 300 participants or for six months, whatever arises first. Participants can only be recruited once during the study period.

Eligibility criteria: Inclusion Criteria:

* \>30 years of age
* Referral to the rapid access chest pain clinic with possible new onset or worsening angina

Exclusion Criteria:

* Inability to give informed consent.
* Previous recruitment to the study.
* Acute coronary syndrome within 3 months.

Primary outcomes:
measure: Proportion of participants in whom a chest pain risk assessment is complete within one working day of referral.
timeFrame: This is the time from referral to rapid access chest pain clinic through to completion of their visit, anticipated to be between 1 and 3 days.
Secondary outcomes:
measure: Proportion of patients who can have their risk assessment completed in one, two or three or more working days from referral to service until completion of risk assessment.
timeFrame: This is the time from referral to rapid access chest pain clinic through to completion of their visit, anticipated to be between 1 and 3 days.
measure: Proportion of valid and interpretable point-of-care troponin tests
timeFrame: This will be completed during the patients study visit, anticipated to last 1 hour
measure: Proportion of personal electrocardiograms that are interpretable
timeFrame: This will be completed during the patients study visit, anticipated to last 1 hour
measure: Proportion of participants stratified as low, intermediate, or high risk using objective risk stratification.
timeFrame: This will be completed during the patients study visit, anticipated to last 1 hour
measure: Proportion of participants with and without a clinical diagnosis of angina stratified as low, intermediate, or high risk and according to triage status.
timeFrame: This will be obtained at 3 months following completion of the patient's assessment.
measure: Proportion of participants with unscheduled Emergency Department attendance(s) at 3 months stratified as low, intermediate, or high risk and according to triage status.
timeFrame: This will be obtained at 3 months following completion of the patient's assessment.
measure: Proportion of participants with cardiac death or non-fatal myocardial infarction at 3 months stratified as low, intermediate, or high risk and according to triage.
timeFrame: This will be obtained at 3 months following completion of the patient's assessment.
Other outcomes:
measure: Proportion of participants reclassified as low, intermediate, or high risk using standard laboratory assays compared to point-of-care high-sensitivity cardiac troponin assay.
timeFrame: This will be completed during the patients study visit, anticipated to last 1 hour
measure: Proportion of participants reclassified as low, intermediate, or high risk using standard 12-lead compared to personal 12-lead electrocardiography
timeFrame: This will be completed during the patients study visit, anticipated to last 1 hour
Locations:
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
Study officials:
affiliation: University of Edinburgh
name: Michael McDermott, MBCHB
role: PRINCIPAL_INVESTIGATOR
References: