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NCT Number: NCT07696533

ULTIMATE Study (Carotid Ultrasound Vs CT Coronary Calcium Scoring to Reclassify Symptomatic Patients With Chronic Coronary Syndrome)

* 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwick Park Hospital

Harrow, HA1 3UJ, United Kingdom

Location status: Recruiting

Location contact

Emma Howard

CONTACT

[email protected]

+44 0208 869 2548

Roxy Senior, Prof

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Carotid ultrasound

Diagnostic Test

Carotid ultrasound

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Howard

CONTACT

[email protected]

+4402088692548

Sponsors and collaborators

Lead sponsor

London North West Healthcare NHS Trust

Other

Registry information

Official study 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

Acronym: ULTIMATE

Important dates

Study start
2026
Primary completion
2027
Study completion
2032
First posted
Jul 10, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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