Ignite Creation Date:
2024-05-06 @ 3:41 AM
Last Modification Date:
2024-10-26 @ 11:37 AM
Study NCT ID:
NCT02346565
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2015-01-14
Brief Title:
Stress Echocardiography Versus Exercise ECG ExECG in Women With Chest Pain
Sponsor:
London North West Healthcare NHS Trust
Organization:
London North West Healthcare NHS Trust
Study Overview
Official Title:
The Role of Contemporary Stress Echocardiography Techniques in the Initial Assessment of Women With No Previous History of Coronary Artery Disease CAD Who Present With Chest Pain of Recent Onset Stress Echocardiography vs Exercise ECG as First Line Investigation in This Population Potential for Higher Diagnostic Accuracy Cost Saving
Status:
COMPLETED
Status Verified Date:
2022-04
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:
None
Brief Summary:
The overall question the investigators would like to help answer is whether SE with or without MCE data can be widely used as a first line investigation in women with no previous history of Coronary Artery Disease CAD who present with chest pain of recent onset In order to answer this question the investigators will look at the following
i Is SE superior to ExECG in terms of cost to diagnosis and negative predictive value of CAD
ii What is the additive value of myocardial perfusion data to wall motion data for predicting significant CAD on angiography and future cardiac events in women
iii What is the additive value of Carotid ultrasonography in a large population of women referred for stress testing
i Is SE superior to ExECG in terms of cost to diagnosis and negative predictive value of CAD
ii What is the additive value of myocardial perfusion data to wall motion data for predicting significant CAD on angiography and future cardiac events in women
iii What is the additive value of Carotid ultrasonography in a large population of women referred for stress testing
Detailed Description:
The investigators plan to perform a prospective study on all women seen in our RACPC with no previous history of CAD and intermediate pre-test probability of CAD as determined by National Institute for Health and Care Excellence NICE guidelines who require a functional test as part of their assessment All patients that meet the inclusion criteria and do not meet any of the exclusion criteria will be approached for consent to the study
Patients who can perform greater than 5 metabolic equivalents METS on the Duke Activity Status Index DASI questionaire will be randomised between undergoing an Exercise ECG Ex-ECG or Exercise Stress Echo ESE The DASI is a 12-item questionnaire that estimates self-reported physical work capacity and is converted to an estimate of peak metabolic equivalents Patients who do not meet this criteria will undergo a pharmacological stress echocardiogram using Dobutamine DSE including Myocardial Contrast Echocardiography MCE Investigations will continue to be performed as per standard clinical departmental protocols as described below In addition all patients will undergo carotid ultrasonography The techniques used are described for completeness as they are all well-established in clinical practice
Patients who can perform greater than 5 metabolic equivalents METS on the Duke Activity Status Index DASI questionaire will be randomised between undergoing an Exercise ECG Ex-ECG or Exercise Stress Echo ESE The DASI is a 12-item questionnaire that estimates self-reported physical work capacity and is converted to an estimate of peak metabolic equivalents Patients who do not meet this criteria will undergo a pharmacological stress echocardiogram using Dobutamine DSE including Myocardial Contrast Echocardiography MCE Investigations will continue to be performed as per standard clinical departmental protocols as described below In addition all patients will undergo carotid ultrasonography The techniques used are described for completeness as they are all well-established in clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None