Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2025-12-17 @ 3:52 PM
Study NCT ID:
NCT06325020
Status:
None
Last Update Posted:
2025-09-03 00:00:00
First Post:
2024-03-06 00:00:00
Brief Title:
Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology
Sponsor:
University of Edinburgh
Organization:
University of Edinburgh
Study Overview
Official Title:
ORACLE: Objective Risk Assessment in Patients With Possible Anginal Chest Pain Using Leading Technology
Status:
None
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:
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.
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 ngl 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 ngl 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:
None
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?:
None