Chronic Coronary SyndromeULTIMATENCT07696533
ULTIMATE Study (Carotid Ultrasound Vs CT Coronary Calcium Scoring to Reclassify Symptomatic Patients With Chronic Coronary Syndrome)
A study testing Carotid Ultrasound in people with Chronic Coronary Syndrome and Obstructive Coronary Artery Disease, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Chest pain is one of the most common symptoms of heart disease. This could be due to narrowing in heart's blood vessels, which needs to be investigated. Currently, people with a low risk of narrowing of heart vessels usually have a CT scan of the heart first. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome, Obstructive Coronary Artery Disease
- What is being tested?
- Carotid Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jul 2026to 30 Nov 2032
- 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
- Symptomatic patients with suspected CCS, judged by the clinician to require CTCA with CAC scoring, for the diagnosis of CAD
- Have a RF-CL 5-15%, as calculated using ESC guidelines
- Able to give informed consent to participate in the study and its follow up
Who cannot join
- Age <18 years old
- Diagnosed ACS requiring hospitalization or urgent or emergent testing
- Known CAD with prior MI, PCI, CABG or any angiographic evidence of CAD (≥50% lesion in a major epicardial vessel)
- History of previous stroke or known peripheral vascular disease
- Known significant cardiac congenital abnormalities
- Pregnancy
- Life expectancy < 1 years
- Unable to provide written 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
Northwick Park Hospital
Harrow, HA1 3UJ
Emma Howard, +44 0208 869 2548, lnwh-tr.cardiacresearch@nhs.net
Roxy Senior, Prof
About this study
Official title: Carotid Ultrasound Vs Computed Tomography (CT) Coronary Calcium Scoring to Reclassify Symptomatic Patients With Suspected Chronic Coronary Syndrome Using Risk Factor Clinical Likelihood for Obstructive Coronary Artery Disease
- Chest pain is one of the most common symptoms of heart disease. This could be due to narrowing in heart's blood vessels, which needs to be investigated.
- Currently, people with a low risk of narrowing of heart vessels usually have a CT scan of the heart first. This scan is good at identifying those who do not have significant narrowing. However, the scan has some drawbacks, such as exposure to a small amount of radiation.
- We are exploring if ultrasound of the neck vessels might give us similar kind of information as the CT scan.
- You will be asked to attend the hospital for one visit to have an ultrasound scan of your neck.
- The findings of your neck vessels will be compared with the CT scan of your heart vessels to see if there is a similarity.
Read the detailed description
In the era of rising coronary artery disease burden, various investigations ranging from CTCA, SE, CMR, PET, SPECT and CA are being extensively relied upon to detect CAD and prevent CVD events. According to current guidelines, patients falling in the subgroup of low likelihood of obstructive CAD are investigated with CTCA and CAC score as the first line of investigation to rule out obstructive coronary artery disease [6,8]. Based on the CACS-CL alone, the low-risk RF-CL patients can be reclassified to identify more patients with very low risk of obstructive CAD, thereby allowing for deferral of further testing [6]. This method has demonstrated a high degree of reliability in the process of downgrading patients from the low-likelihood subgroup to the very-low-likelihood of obstructive CAD subgroup [29]. The reclassification of patients to the 'very low likelihood of obstructive CAD' subgroup is important, as it ensures that patients can be safely reassured, with no further requirement for investigations for obstructive CAD and at the same time reduces pressure on already compromised resources. In order to determine the CAC score, patients are exposed to ionising radiation. It is not only expensive but also requires advanced equipment, while carotid ultrasound offers a safer, quicker and more affordable option without radiation. With growing evidence connecting carotid plaque with CAD in both asymptomatic and symptomatic individuals, its role in risk reclassification of symptomatic patients warrants further investigation. The objective of this study is to determine the accuracy of carotid ultrasound in reclassifying a specific patient subgroup compared to CAC score. Should carotid ultrasound be able to demonstrate the desired accuracy as of CAC score in this sub-group, it would be feasible to investigate such patients without exposure to ionising radiation or iodinated contrast, while concomitantly reducing costs.
- Being tested
- Carotid Ultrasound
- Keywords
- Carotid Ultrasound, Computed Tomography Coronary Calcium Scoring, Chronic Coronary Syndrome, Obstructive Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid UltrasoundDiagnostic test
Carotid ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Carotid Ultrasound | Experimental | Not described Receives: Diagnostic Test: Carotid Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Reclassification of patients based on detection of carotid plaques defined as: a. Patients with no carotid plaques will reclassify as very low likelihood (<5%) b. Patients with 1-2 plaques as low likelihood for obstructive CAD (5-15%) c. Patients with
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start3 Jul 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2032 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
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
- NCT07696533
- Sponsor's protocol ID
- CRC/2025/001
- Other IDs
- 364694
- Acronym
- ULTIMATE
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 15 Jul 2026
- 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Ultrasound Vs Computed Tomography (CT) Coronary Calcium Scoring to Reclassify Symptomatic Patients With Suspected Chronic Coronary Syndrome Using Risk Factor Clinical Likelihood for Obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07696533
- Acronym / sponsor ID
- ULTIMATE / CRC/2025/001
- Keywords
- Carotid Ultrasound, Computed Tomography Coronary Calcium Scoring, Chronic Coronary Syndrome, Obstructive Coronary Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 3 Jul 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2032 (estimated)
- First posted
- 10 Jul 2026 (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.
- Chest pain is one of the most common symptoms of heart disease. This could be due to narrowing in heart's blood vessels, which needs to be investigated.
- Currently, people with a low risk of narrowing of heart vessels usually have a CT scan of the heart first. This scan is good at identifying those who do not have significant narrowing. However, the scan has some drawbacks, such as exposure to a small amount of radiation.
- We are exploring if ultrasound of the neck vessels might give us similar kind of information as the CT scan.
- You will be asked to attend the hospital for one visit to have an ultrasound scan of your neck.
- The findings of your neck vessels will be compared with the CT scan of your heart vessels to see if there is a similarity.
Detailed description
In the era of rising coronary artery disease burden, various investigations ranging from CTCA, SE, CMR, PET, SPECT and CA are being extensively relied upon to detect CAD and prevent CVD events. According to current guidelines, patients falling in the subgroup of low likelihood of obstructive CAD are investigated with CTCA and CAC score as the first line of investigation to rule out obstructive coronary artery disease [6,8]. Based on the CACS-CL alone, the low-risk RF-CL patients can be reclassified to identify more patients with very low risk of obstructive CAD, thereby allowing for deferral of further testing [6]. This method has demonstrated a high degree of reliability in the process of downgrading patients from the low-likelihood subgroup to the very-low-likelihood of obstructive CAD subgroup [29]. The reclassification of patients to the 'very low likelihood of obstructive CAD' subgroup is important, as it ensures that patients can be safely reassured, with no further requirement for investigations for obstructive CAD and at the same time reduces pressure on already compromised resources. In order to determine the CAC score, patients are exposed to ionising radiation. It is not only expensive but also requires advanced equipment, while carotid ultrasound offers a safer, quicker and more affordable option without radiation. With growing evidence connecting carotid plaque with CAD in both asymptomatic and symptomatic individuals, its role in risk reclassification of symptomatic patients warrants further investigation. The objective of this study is to determine the accuracy of carotid ultrasound in reclassifying a specific patient subgroup compared to CAC score. Should carotid ultrasound be able to demonstrate the desired accuracy as of CAC score in this sub-group, it would be feasible to investigate such patients without exposure to ionising radiation or iodinated contrast, while concomitantly reducing costs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carotid Ultrasound | Experimental | Diagnostic Test: Carotid Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Symptomatic patients with suspected CCS, judged by the clinician to require CTCA with CAC scoring, for the diagnosis of CAD
- Have a RF-CL 5-15%, as calculated using ESC guidelines
- Able to give informed consent to participate in the study and its follow up
Key exclusion criteria (8 listed)
- Age <18 years old
- Diagnosed ACS requiring hospitalization or urgent or emergent testing
- Known CAD with prior MI, PCI, CABG or any angiographic evidence of CAD (≥50% lesion in a major epicardial vessel)
- History of previous stroke or known peripheral vascular disease
- Known significant cardiac congenital abnormalities
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 |
|---|---|---|
| Carotid UltrasoundCarotid ultrasound | Diagnostic test | Carotid Ultrasound |
Primary outcome
1. Reclassification of patients based on detection of carotid plaques defined as: a. Patients with no carotid plaques will reclassify as very low likelihood (<5%) b. Patients with 1-2 plaques as low likelihood for obstructive CAD (5-15%) c. Patients with
Time frame: 12 months
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 15 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid Ultrasound in people with Chronic Coronary Syndrome and Obstructive 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 4 inclusion and 8 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 15 Jul 2026. 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 (+4402088692548, lnwh-tr.cardiacresearch@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Reclassification of patients based on detection of carotid plaques defined as: a. Patients with no carotid plaques will reclassify as very low likelihood (<5%) b. Patients with 1-2 plaques as low likelihood for obstructive CAD (5-15%) c. Patients with (time frame: 12 months). 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 15 Jul 2026.