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High Frame Rate Ultrasound in Heart Disease Assessment

High Frame Rate Contrast Enhanced-ultrasound for the Assessment of Ischaemic Heart Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03850015
Acronym
RUFUS-Heart
Enrollment
25
Registered
2019-02-21
Start date
2022-02-01
Completion date
2025-09-30
Last updated
2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

echocardiography

Brief summary

The study will compare standard ultrasound images to high frame rate ultrasound images in patients with heart disease or with a low risk of heart disease to see if a higher frame rate of ultrasound adds to the information obtained from standard ultrasound.

Detailed description

Following informed consent, patients recruited for the study will have an IV cannula inserted and will undergo imaging using 2 ultrasound systems. Standard clinical system (Philips IE33) will be used for 2D and CE imaging, followed by imaging using the Verasonics VantageTM research system (Verasonics Inc., Redmond, WA), using both conventional 2D and HFR modes. Baseline unenhanced 2D and Doppler images would initially be acquired using Philips IE33 system and Verasonics VatangeTM unenhanced conventional 2D and HFR mode . Ultrasound contrast agent (Sonovue) will be then injected via the intravenous (iv) cannula and 3 sets rest contrast images will be acquired - using the Phillips IE33, Verasonics and Verasonics VantageTM platform (conventional CE and HFR CE). Both systems will be optimised separately on each patient before and during infusion of contrast agent. When the optimal imaging and destruction parameters are set, there are not modified along the acquisition. This is followed by dipyridamole infusion and the scans being repeated during stress - 3 sets contrast images will be acquired - using the Philips IE33 and Verasonics VantageTM platform (conventional CE and HFR CE).

Interventions

Patients will undergo standard echocardiography, with and without contrast

Following standard echocardiography, the test is repeated using high frame rate ultrasound

Sponsors

London North West Healthcare NHS Trust
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Either * Ability to give informed consent * age ≥18years and * confirmed inducible wall motion / perfusion abnormality on previous stress echocardiogram * known coronary artery disease - defined by presence of flow-limiting coronary stenosis(\>70% diameter stenosis) on coronary angiography. OR • patient who has been assessed as at low risk of having coronary heart disease

Exclusion criteria

* Inability to undertake pharmacological stress, ie previously known intolerance to dipyridamole; * Moderate or Severe aortic or mitral regurgitation or severe mitral stenosis; * Significant pulmonary disease like severe COPD or pulmonary fibrosis; * Atrial fibrillation; * Inability to provide informed consent; * Pregnancy and lactation; * Known allergy to Sonovue * Patients with second and third degree heart block, unless they have a pacemaker fitted * Systolic BP \< 90 * Known Myasthenia Gravis * Bronchial asthma

Design outcomes

Primary

MeasureTime frameDescription
Agreement between HFR ultrasound and standard ultrasound.At 1 yearDemonstration that there is at least 80% agreement between HFR ultrasound techniques and standard techniques. Expressed as as a percentage of the recorded images.

Countries

United Kingdom

Contacts

Primary ContactEmma Howard, MSc
emma.howard16@nhs.net+442088692547
Backup ContactLasha Gvinianidze, MD
lasha.gviniandze1@nhs.net+442088692547

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026