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

NCT07696533 | Recruiting

• 2 other identifiers: CRC/2025/001364694
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Coronary Syndrome; Obstructive Coronary Artery Disease

Keywords

Carotid Ultrasound; Computed Tomography Coronary Calcium Scoring; Chronic Coronary Syndrome; Obstructive Coronary Disease

Outcome Measures

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

  12 months

Study Arms (1)

Carotid Ultrasound

EXPERIMENTAL

Diagnostic Test: Carotid Ultrasound

Interventions

Carotid Ultrasound DIAGNOSTIC_TEST

Carotid ultrasound

Carotid Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

Northwick Park Hospital

Harrow, HA1 3UJ, United Kingdom

RECRUITING

MeSH Terms

Interventions

Ultrasonography, Carotid Arteries

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Emma Howard

CONTACT

+4402088692548; lnwh-tr.cardiacresearch@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 3, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2032
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)