Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT06325020
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2024-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology
Sponsor:
University of Edinburgh
Organization:
Study Overview
Official Title:
ORACLE: Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ORACLE
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: