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

6. juli 2026 opdateret af: London North West Healthcare NHS Trust

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

225

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age > 18 years old
  2. Symptomatic patients with suspected CCS, judged by the clinician to require CTCA with CAC scoring, for the diagnosis of CAD
  3. Have a RF-CL 5-15%, as calculated using ESC guidelines
  4. Able to give informed consent to participate in the study and its follow up

Exclusion Criteria:

  1. Age <18 years old
  2. Diagnosed ACS requiring hospitalization or urgent or emergent testing
  3. Known CAD with prior MI, PCI, CABG or any angiographic evidence of CAD (≥50% lesion in a major epicardial vessel)
  4. History of previous stroke or known peripheral vascular disease
  5. Known significant cardiac congenital abnormalities
  6. Pregnancy
  7. Life expectancy < 1 years
  8. Unable to provide written informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Carotid Ultrasound
Diagnostisk test: Carotid Ultrasound
Carotid ultrasound

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: 12 months
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

London North West Healthcare NHS Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

3. juli 2026

Primær færdiggørelse (Anslået)

30. november 2027

Studieafslutning (Anslået)

30. november 2032

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

6. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRC/2025/001
  • 364694 (Anden identifikator: IRAS)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Kronisk koronarsyndrom

Kliniske forsøg med Carotid Ultrasound

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Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Togo

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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