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NCT Number: NCT03850015

High Frame Rate Ultrasound in Heart Disease Assessment

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

London North West University Healthcare NHS Trust

Harrow, Middx, HA1 3UJ, United Kingdom

Location status: Recruiting

Location contact

Nana Theodorou

CONTACT

[email protected]

Sunder Chita

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Standard echocardiography

Diagnostic Test

Patients will undergo standard echocardiography, with and without contrast

High frame rate echocardiography

Other

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

Primary outcomes

  1. Agreement between HFR ultrasound and standard ultrasound.

    Time frame: At 1 year

    Demonstration that there is at least 80% agreement between HFR ultrasound techniques and standard techniques. Expressed as as a percentage of the recorded images.

Study contacts

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

Emma Howard, MSc

CONTACT

[email protected]

+442088692547

Lasha Gvinianidze, MD

CONTACT

[email protected]

+442088692547

Sponsors and collaborators

Lead sponsor

London North West Healthcare NHS Trust

Other

Registry information

Official study title

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

Acronym: RUFUS-Heart

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2019
Registry last updated
May 23, 2025

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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