Stress Echocardiography Versus Exercise ECG (ExECG) in Women With Chest Pain
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.
1 other identifier
interventional
416
1 country
1
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Jan 2015
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 14, 2015
CompletedFirst Posted
Study publicly available on registry
January 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedOctober 20, 2022
April 1, 2022
7.7 years
January 14, 2015
October 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Comparison of Positive Predictive Value of each test for Coronary artery disease detection
To compare positive predictive value of each test for the detection of obstructive CAD defined as ≥ 70% luminal diameter narrowing in one or more epicardial coronary arteries or their major branches during invasive coronary arteriography
2 years
To compare the use of Downstream resource utilisation following allocated functional tests
Comparison between the number of follow-up investigations, clinic visits and hospitalisation for patients in the 2 test groups.
2 years
Study Arms (2)
Exercise ECG
OTHERPatients will undergo an exercise test using the standard Bruce protocol. Standard end points of exercise testing will include: fatigue, severe ischaemia (severe chest pain, \>2mm ST depression on ECG), hypertension (systolic BP\>220mmHg), hypotension, pre-syncope or arrhythmia.
Stress Echocardiography
OTHERA two-dimensional echocardiogram will be performed in the lateral decubitus position. Digitized images of the left ventricle (LV) will be obtained in the parasternal long-axis, short-axis, and apical four-, two-, and three-chamber views. In the case of exercise stress echo, images will be acquired at rest and immediately (within 90 seconds) after peak exercise. In the case of dobutamine stress echo, images will be acquired at rest, at the end of stage one of dobutamine administration (10mcg/Kg/min) and at peak stress.
Interventions
Eligibility Criteria
You may qualify if:
- Age 30 years and above
- No previous history of Coronary Artery Disease
- Chest pain of presumed cardiac origin, which has occurred in the last month prior to the clinic appointment.
You may not qualify if:
- Electrocardiogram diagnostic of cardiac ischaemia and/or infarction (ST-segment deviations\>0.5mm, or T-wave inversion).
- Previous history of Coronary Artery Disease
- Chest pain in the last 24 hours
- Inability to provide informed consent
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwick Park Hospital
Harrow, Middx, HA1 3UJ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2015
First Posted
January 27, 2015
Study Start
January 1, 2015
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
October 20, 2022
Record last verified: 2022-04