protocolSection identificationModule nctId: NCT06325020, orgStudyIdInfo id: 337367, briefTitle: Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology, acronym: ORACLE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2024-11-01, completionDateStruct date: 2025-02-28, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-22, sponsorCollaboratorsModule leadSponsor name: University of Edinburgh, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Angina, Stable, conditions: Coronary Artery Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: The assessment of patients with possible angina using the ORACLE pathway, outcomesModule primaryOutcomes measure: Proportion of participants in whom a chest pain risk assessment is complete within one working day of referral., secondaryOutcomes 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., secondaryOutcomes measure: Proportion of valid and interpretable point-of-care troponin tests, secondaryOutcomes measure: Proportion of personal electrocardiograms that are interpretable, secondaryOutcomes measure: Proportion of participants stratified as low, intermediate, or high risk using objective risk stratification., secondaryOutcomes measure: Proportion of participants with and without a clinical diagnosis of angina stratified as low, intermediate, or high risk and according to triage status., secondaryOutcomes 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., secondaryOutcomes 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., otherOutcomes 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., otherOutcomes measure: Proportion of participants reclassified as low, intermediate, or high risk using standard 12-lead compared to personal 12-lead electrocardiography, eligibilityModule sex: ALL, minimumAge: 30 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False