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

NCT06325020 | Active Not Recruiting

• 1 other identifier: 337367
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Angina, Stable; Coronary Artery Disease

Keywords

angina, chest pain, cardiac troponin, risk stratification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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.

  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.

• Proportion of valid and interpretable point-of-care troponin tests

  This will be completed during the patients study visit, anticipated to last 1 hour

• Proportion of personal electrocardiograms that are interpretable

  This will be completed during the patients study visit, anticipated to last 1 hour

• Proportion of participants stratified as low, intermediate, or high risk using objective risk stratification.

  This will be completed during the patients study visit, anticipated to last 1 hour

• 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 obtained at 3 months following completion of the patient's assessment.

Other Outcomes (2)

• Proportion of participants reclassified as low, intermediate, or high risk using standard laboratory assays compared to point-of-care high-sensitivity cardiac troponin assay.

  This will be completed during the patients study visit, anticipated to last 1 hour

• Proportion of participants reclassified as low, intermediate, or high risk using standard 12-lead compared to personal 12-lead electrocardiography

  This will be completed during the patients study visit, anticipated to last 1 hour

Study Arms (1)

Patients with possible angina

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.

Other: The assessment of patients with possible angina using the ORACLE pathway

Interventions

The assessment of patients with possible angina using the ORACLE pathway OTHER

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.

Patients with possible angina

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood will be taken from participants, with their consent, and stored to allow for future biomarker exploration.

MeSH Terms

Conditions

Angina, Stable; Coronary Artery Disease; Angina Pectoris; Chest Pain

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Michael McDermott, MBCHB

  University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 22, 2024
• Study Start: July 4, 2024
• Primary Completion: July 21, 2025
• Study Completion: March 1, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)