Coronary Artery DiseaseNCT02346565
Stress Echocardiography Versus Exercise ECG (ExECG) in Women With Chest Pain
A study testing Exercise ECG and Stress Echocardiography in people with Coronary Artery Disease, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Exercise ECG and Stress Echocardiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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:
- 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?
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Exercise ECG, Stress Echocardiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ECGProcedure or surgery
Stress EchocardiographyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Exercise ECG | Other | Patients 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. Receives: Procedure: Exercise ECG |
| Stress Echocardiography | Other | A 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. Receives: Procedure: Stress Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2022
- Study completionSep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346565
- Sponsor's protocol ID
- RD14/86
- Status last verified
- Apr 2022
- First submitted
- 14 Jan 2015
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02346565
- Acronym / sponsor ID
- RD14/86
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Sep 2022 (actual)
- Study completion
- Sep 2022 (actual)
- First posted
- 27 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise ECG | Other | Procedure: Exercise ECGPatients 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 | Other | Procedure: Stress EchocardiographyA 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ECG | Procedure or surgery | Exercise ECG |
| Stress Echocardiography | Procedure or surgery | Stress Echocardiography |
Primary outcome
Comparison of Positive Predictive Value of each test for Coronary artery disease detection
Time frame: 2 years
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
To compare the use of Downstream resource utilisation following allocated functional tests
Time frame: 2 years
Comparison between the number of follow-up investigations, clinic visits and hospitalisation for patients in the 2 test groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise ECG and Stress Echocardiography in people with Coronary Artery Disease, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Positive Predictive Value of each test for Coronary artery disease detection (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.