Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology

Coronary Artery Disease Clinical Trial

— ORACLE  

Official title:

ORACLE: Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06325020
• Other study ID #: 337367
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: University of Edinburgh
• Contact: Michael McDermott, MBChB
• Phone: 07966024516
• Email: michael.mcdermott[@]ed.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: February 28, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angina, Stable
• Chest Pain
• Coronary Artery Disease

Intervention

Other:
• The assessment of patients with possible angina using the ORACLE pathway
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. The results of all of the above will allow patients to be started as low, intermediate or high risk for future cardiovascular events.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Edinburgh

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of participants reclassified as low, intermediate, or high risk using standard laboratory assays compared to point-of-care high-sensitivity cardiac troponin assay.	Patients will have a point of care troponin and a core laboratory high sensitivity troponin. The proportion of patients who are re-classified by the current laboratory clinical standard will be recorded	This will be completed during the patients study visit, anticipated to last 1 hour
Other	Proportion of participants reclassified as low, intermediate, or high risk using standard 12-lead compared to personal 12-lead electrocardiography	Patients will have a standard 12 lead and personal ECG. The proportion of patients who are re-classified by the current clinical standard 12 lead ECG will be recorded.	This will be completed during the patients study visit, anticipated to last 1 hour
Primary	Proportion of participants in whom a chest pain risk assessment is complete within one working day of referral.	The proportion of participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in whom a complete risk assessment is delivered in a community setting using point of care and patient facing technologies within one working day of referral.	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	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.	The proportion of participants who have been referred by their primary care provider to the rapid access chest pain clinic with possible angina in whom a complete risk assessment is delivered in a community setting using point of care and patient facing technologies within one, two or three or more working days of referral.	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	Proportion of valid and interpretable point-of-care troponin tests	This will be the proportion of patients in whom a valid high sensitivity cardiac troponin result can be obtained from undertaking the point of care assay.	This will be completed during the patients study visit, anticipated to last 1 hour
Secondary	Proportion of personal electrocardiograms that are interpretable	This will be the proportion of patients in whom an interpretable personal ECG has been performed	This will be completed during the patients study visit, anticipated to last 1 hour
Secondary	Proportion of participants stratified as low, intermediate, or high risk using objective risk stratification.	This will be the proportion of patients who are stratified into low, intermediate or high risk groups on completion of their risk assessment.	This will be completed during the patients study visit, anticipated to last 1 hour
Secondary	Proportion of participants with and without a clinical diagnosis of angina stratified as low, intermediate, or high risk and according to triage status.	This will be the proportion of patients who do and do not receive a clinical diagnosis of angina and this will be stratified by triage status	This will be obtained at 3 months following completion of the patient's assessment.
Secondary	Proportion of participants with unscheduled Emergency Department attendance(s) at 3 months stratified as low, intermediate, or high risk and according to triage status.	This will be the proportion of patients who present acutely to the emergency department in the 3 months following assessment. This will be stratified by risk stratification and their clinical triage status.	This will be obtained at 3 months following completion of the patient's assessment.
Secondary	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.	This will be the proportion of patients who have cardiac death or fatal myocardial infarction in the 3 months following assessment. This will be stratified by risk stratification and their clinical triage status.	This will be obtained at 3 months following completion of the patient's assessment.