Chronic Coronary SyndromeSECURENCT06185530
SECURE Trial: Stress Echocardiography With Carotid Ultrasound vs Routine CT Coronary Angiography in Chronic Coronary Syndrome for Endpoints
A study testing Detection of obstructive coronary disease in people with Chronic Coronary Syndrome and Coronary Disease, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Diseases of the heart and circulation are known as cardiovascular diseases, and they cause over 160,000 deaths each year. Coronary heart disease (CHD) is the most common cardiovascular disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome, Coronary Disease, Coronary Artery Disease
- What is being tested?
- Detection of obstructive coronary disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Sep 2023to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Patients referred to RACPC and judged by the reviewer to require a further imaging investigation, either SE or CTCA, to evaluate a suspected diagnosis of CAD
- AND
- Have a PTP score ≥ 5%, as calculated using ESC guidelines OR
- Have clinical history in keeping with 'typical' angina symptoms, as judged by the investigator, in patients with a PTP score <5% - With 'typical' symptoms, as per ESC guidelines, being all three of the following
- Constricting symptoms in the front of the chest or in the neck, jaw, shoulder or arm ii) Precipitated by physical exertion iii) Relieved by rest or nitrates within 5 minutes
- Able to give informed consent to participate in the study and its follow up
Who cannot join
- Patients with diagnosed ACS that require urgent or emergency treatment or hospitalisation for inpatient investigations.
- Known history of obstructive CAD (Previous MI, PCI or CABG) or previous invasive angiography with evidence of ≥ 50% stenosis in any epicardial vessel.
- Patients who have undergone invasive or non-invasive, functional or anatomical (Including CAC score) testing for detection of CAD within the previous 1 year of clinical assessment.
- Documented allergy to iodinated contrast or documented allergy to both ultrasound contrasts used at LNWH Trust; Luminity® (Perflutren) and SonoVue® (Sulphur Hexafluoride) or the constitutes
- Contraindications to undergoing CTCA, including but not limited to;
- eGFR < 40 ml/min
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- Contraindications to beta-blockers including but not limited to, documented allergy or significant airways disease in the judgement of the investigator.
- Exceeding CT scanner weight tolerance
- Contraindications to undergoing SE, including but not limited to;
- Known cardiomyopathic process (Hypertrophic cardiomyopathy (HCM)) with resting gradient > 50mmHg or severe valvular lesion
- Severe uncontrolled hypertension (≥180/100mmHg)
- Known pregnancy
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
London North West University Healthcare NHS Trust
Harrow, Middx, HA1 3UJ
Sunder Chita, sunderchita@nhs.net
Ann Banfield, annbanfield@nhs.net
About this study
Official title: Stress Echocardiography With Carotid Ultrasound vs Routine CT Coronary Angiography in Suspected Chronic Coronary Syndrome for the Detection of Obstructive Coronary Disease and Prevention of Adverse Outcomes.
Diseases of the heart and circulation are known as cardiovascular diseases, and they cause over 160,000 deaths each year.
Coronary heart disease (CHD) is the most common cardiovascular disease. This is due to a build-up of fatty material, known as atherosclerosis, in the blood vessels supplying blood to the heart muscle. This can cause chest pain or if blocked, can cause a heart attack.
Read more
Two of the main non-invasive tests to look for coronary heart disease are Computed Tomography Coronary Angiography (CTCA) and Stress Echocardiography (Ultrasound scan).
CTCA shows the arteries and allows small amounts of disease to be seen that may not yet be causing any symptoms. However, if there's lots of disease and calcification, it becomes difficult to tell how severe it is, which means several tests may be needed. Stress Echocardiography shows if enough blood is reaching the heart muscle, so can show if there is severe disease that needs treatment. However, it can't see the arteries so doesn't showt small disease that may benefit from tablet treatment. There is not yet an effective non-invasive combined test that can give all this information in one go.
Studies have shown that if there's atherosclerosis in another artery, a person is very likely to have coronary atherosclerosis as well. Carotid atherosclerosis, in the neck arteries, can be seen with ultrasound similar to stress echocardiography. So, by combining these two tests the investigators want to see if it is possible to see severe as well as small areas of disease in one test, to provide better treatment.
The study will enrol 2,000 participants, who need investigation for CHD, equally randomised to CTCA or stress echocardiography with carotid ultrasound. We will follow these participants for 5 years and observe for any adverse outcomes and ask them to complete a questionnaire.
- Being tested
- Detection of obstructive coronary disease
- Keywords
- CTCA, Stress Echocardiography, Carotid Ultrasound
- Medical subject headings
- Coronary Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of obstructive coronary diseaseDiagnostic test
Detection of obstructive coronary disease
| Study group | Role | What they receive |
|---|---|---|
| Participants undergo the cardiac tests: stress echocardiography with carotid ultrasound | Experimental | Not described Receives: Diagnostic Test: Detection of obstructive coronary disease |
| Participants undergo the cardiac test: CT coronary angiography | Active comparator | Not described Receives: Diagnostic Test: Detection of obstructive coronary disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of obstructive CAD and prevalence of MACE in enrolled participants
Measured: Within 3 months of randomisation confirmed by documentation in medical record
Secondary outcomes (6)
Assessment of resource utilisation between study arms (subsequent downstream testing, cardiac related hospital visits, costs and incremental cost effectiveness)
Measured: Time to first event, up to 18 months post randomisation, confirmed by medical record documentation
Assessment of overall ionising radiation exposure (dose) between study arms
Measured: Within 3 months of randomisation, confirmed by documentation in investigation report
Major complications from cardiovascular procedures or cardiovascular diagnostic testing
(a. Haemodynamically unstable new arrhythmia requiring emergency respiratory and/or circulatory support b. Anaphylaxis defined as a new severe reaction requiring emergency respiratory and/or circulatory support to administration of medication, including but not limited to; iodinated contrast, ultrasound contrast, dobutamine or atropine.
- Major bleeding requiring a transfusion of ≥ 1 unit of packed red blood cells and/or further interventional procedures related to bleeding management.
- Acute severe renal failure requiring ≥ 1 cycle of renal replacement therapy. e. Stroke defined as sudden onset focal neurological deficit with cerebral imaging confirming new stroke)
Measured: Up to18 months from randomisation to time of first documented outcome in medical records
Analysis of patient derived chest pain related quality of life (EQ-5D)
Measured: at 6-months and 12-months after randomisation on telephonecall questionnaire completion with patient
Change in prescription of preventative therapies (including statin and anti-platelet agents or dose increase of current statin therapy > 50%)
Measured: Up to 18 months from randomisation to time of first documented outcome in medical records
The proportion of patients undergoing invasive coronary angiography and revascularisation, of the target lesion, either through PCI or CABG, at follow up.
Measured: Time (in days) from the initial investigation until revascularisation confirmed by medical record documentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start18 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Prof Roxy Senior, Principal investigator, LNWH Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06185530
- Sponsor's protocol ID
- CRC/2023/001
- Acronym
- SECURE
- Status last verified
- Oct 2025
- First submitted
- 31 May 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Echocardiography With Carotid Ultrasound vs Routine CT Coronary Angiography in Suspected Chronic Coronary Syndrome for the Detection of Obstructive Coronary Disease and Prevention of Adverse Outcomes.
- ClinicalTrials.gov ID
- NCT06185530
- Acronym / sponsor ID
- SECURE / CRC/2023/001
- Keywords
- CTCA, Stress Echocardiography, Carotid Ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 29 Dec 2023 (actual)
- 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.
Diseases of the heart and circulation are known as cardiovascular diseases, and they cause over 160,000 deaths each year.
Coronary heart disease (CHD) is the most common cardiovascular disease. This is due to a build-up of fatty material, known as atherosclerosis, in the blood vessels supplying blood to the heart muscle. This can cause chest pain or if blocked, can cause a heart attack.
Two of the main non-invasive tests to look for coronary heart disease are Computed Tomography Coronary Angiography (CTCA) and Stress Echocardiography (Ultrasound scan).
CTCA shows the arteries and allows small amounts of disease to be seen that may not yet be causing any symptoms. However, if there's lots of disease and calcification, it becomes difficult to tell how severe it is, which means several tests may be needed. Stress Echocardiography shows if enough blood is reaching the heart muscle, so can show if there is severe disease that needs treatment. However, it can't see the arteries so doesn't showt small disease that may benefit from tablet treatment. There is not yet an effective non-invasive combined test that can give all this information in one go.
Studies have shown that if there's atherosclerosis in another artery, a person is very likely to have coronary atherosclerosis as well. Carotid atherosclerosis, in the neck arteries, can be seen with ultrasound similar to stress echocardiography. So, by combining these two tests the investigators want to see if it is possible to see severe as well as small areas of disease in one test, to provide better treatment.
The study will enrol 2,000 participants, who need investigation for CHD, equally randomised to CTCA or stress echocardiography with carotid ultrasound. We will follow these participants for 5 years and observe for any adverse outcomes and ask them to complete a questionnaire.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants undergo the cardiac tests: stress echocardiography with carotid ultrasound | Experimental | Diagnostic Test: Detection of obstructive coronary disease |
| Participants undergo the cardiac test: CT coronary angiography | Active comparator | Diagnostic Test: Detection of obstructive coronary disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years old
- Patients referred to RACPC and judged by the reviewer to require a further imaging investigation, either SE or CTCA, to evaluate a suspected diagnosis of CAD
- AND
- Able to give informed consent to participate in the study and its follow up
Key exclusion criteria (13 listed)
- Patients with diagnosed ACS that require urgent or emergency treatment or hospitalisation for inpatient investigations.
- Known history of obstructive CAD (Previous MI, PCI or CABG) or previous invasive angiography with evidence of ≥ 50% stenosis in any epicardial vessel.
- Patients who have undergone invasive or non-invasive, functional or anatomical (Including CAC score) testing for detection of CAD within the previous 1 year of clinical assessment.
- Documented allergy to iodinated contrast or documented allergy to both ultrasound contrasts used at LNWH Trust; Luminity® (Perflutren) and SonoVue® (Sulphur Hexafluoride) or the constitutes
- Contraindications to undergoing CTCA, including but not limited to;
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 |
|---|---|---|
| Detection of obstructive coronary diseaseDetection of obstructive coronary disease | Diagnostic test | Participants undergo the cardiac test: CT coronary angiography, Participants undergo the cardiac tests: stress echocardiography with carotid ultrasound |
Primary outcome
Detection of obstructive CAD and prevalence of MACE in enrolled participants
Time frame: Within 3 months of randomisation confirmed by documentation in medical record
6 secondary outcomes
Assessment of resource utilisation between study arms (subsequent downstream testing, cardiac related hospital visits, costs and incremental cost effectiveness)
Time frame: Time to first event, up to 18 months post randomisation, confirmed by medical record documentation
Assessment of overall ionising radiation exposure (dose) between study arms
Time frame: Within 3 months of randomisation, confirmed by documentation in investigation report
Major complications from cardiovascular procedures or cardiovascular diagnostic testing
Time frame: Up to18 months from randomisation to time of first documented outcome in medical records
Analysis of patient derived chest pain related quality of life (EQ-5D)
Time frame: at 6-months and 12-months after randomisation on telephonecall questionnaire completion with patient
Change in prescription of preventative therapies (including statin and anti-platelet agents or dose increase of current statin therapy > 50%)
Time frame: Up to 18 months from randomisation to time of first documented outcome in medical records
The proportion of patients undergoing invasive coronary angiography and revascularisation, of the target lesion, either through PCI or CABG, at follow up.
Time frame: Time (in days) from the initial investigation until revascularisation confirmed by medical record documentation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Prof Roxy Senior principal investigator
LNWH Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection of obstructive coronary disease in people with Chronic Coronary Syndrome and Coronary 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 21 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Howard (0208 869 2548, emma.howard16@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of obstructive CAD and prevalence of MACE in enrolled participants (time frame: Within 3 months of randomisation confirmed by documentation in medical record). 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 21 Nov 2025.