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RecruitingNCT06185530SECUREUpdated Nov 21, 2025

SECURE Trial: Stress Echocardiography With Carotid Ultrasound vs Routine CT Coronary Angiography in Chronic Coronary Syndrome for Endpoints

An interventional study of Detection of obstructive coronary disease in Chronic Coronary Syndrome, Coronary Disease and Coronary Artery Disease, sponsored by London North West Healthcare NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-21.

Primary conditionCoronary Artery DiseaseRegistry: Coronary DiseaseReclassifiedWhy we changed it
Registry
Coronary Disease — the first condition term the registry derived for this study.
ClinicalTrials.gg
Coronary Artery Disease
Why
  1. The study's listed conditions name Coronary Artery Disease, a narrower term within Coronary Disease.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by London North West Healthcare NHS Trust · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
2,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Coronary Syndrome
  • Coronary Disease
  • Coronary Artery Disease

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Keywords

  • CTCA
  • Stress Echocardiography
  • Carotid Ultrasound
03

In context

Coronary Artery Disease Reclassified

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

London North West Healthcare NHS Trust is the lead sponsor of 55 studies on the registry; 11 are open to participants now.

Compared within Coronary Artery Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Coronary Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age > 18 years old
  2. 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
  3. AND

    1. Have a PTP score ≥ 5%, as calculated using ESC guidelines OR
    2. 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

    i) 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

  4. Able to give to participate in the study and its follow up

Exclusion criteria

Exclusion Criteria:

  1. Patients with diagnosed ACS that require urgent or emergency treatment or hospitalisation for inpatient investigations.
  2. Known history of obstructive CAD (Previous MI, PCI or CABG) or previous invasive angiography with evidence of ≥ 50% stenosis in any epicardial vessel.
  3. 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.
  4. 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
  5. to undergoing CTCA, including but not limited to;

    • \< 40 ml/min
    • 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
  6. 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)
  7. Known pregnancy
  8. Unable to provide
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,000 participants (estimated)

Study arms

  • Experimental
    Participants undergo the cardiac tests: stress echocardiography with carotid ultrasound

    Diagnostic Test: Detection of obstructive coronary disease

  • Active comparator
    Participants undergo the cardiac test: CT coronary angiography

    Diagnostic Test: Detection of obstructive coronary disease

Interventions

  • Diagnostic testDetection of obstructive coronary disease

    Detection of obstructive coronary disease

06

What researchers measure

Primary outcomes

  1. Detection of obstructive CAD and prevalence of MACE in enrolled participants

    Time frame: Within 3 months of randomisation confirmed by documentation in medical record

Secondary outcomes

  1. 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

  2. Assessment of overall ionising radiation exposure (dose) between study arms

    Time frame: Within 3 months of randomisation, confirmed by documentation in investigation report

  3. 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. c. Major bleeding requiring a transfusion of ≥ 1 unit of packed red blood cells and/or further interventional procedures related to bleeding management. d. 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)

    Time frame: Up to18 months from randomisation to time of first documented outcome in medical records

  4. 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

  5. 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

  6. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Dec 2026, 39 months after the start.

Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 39 months is above that.

Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
May 31, 2023
First posted
Dec 29, 2023
StartActual
Sep 18, 2023
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2031
Last update
Nov 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06185530
Lead sponsor
London North West Healthcare NHS Trust
Responsible party
Sponsor
First posted
Dec 29, 2023
Start date
Sep 18, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2031 (estimated)
Last update
Nov 21, 2025

Study contacts

Emma Howard
Contact
emma.howard16@nhs.net
0208 869 2548
Prof Roxy Senior
principal investigator · LNWH Trust

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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