Coronary Artery DiseaseRUFUS-HeartNCT03850015
High Frame Rate Ultrasound in Heart Disease Assessment
An observational study of Coronary Artery Disease, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Standard echocardiography and High frame rate echocardiography
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2022to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 25 patients will be recruited over 12 months. 5 of these patients will be at low high of having coronary artery disease and 20 at high risk of coronary artery disease. patients will be recruited from those referred for clinical stress stress echocardiography.
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
London North West University Healthcare NHS Trust
Harrow, Middx, HA1 3UJ
Sunder Chita, sunderchita@nhs.net
Nana Theodorou, nana.theodorou1@nhs.net
About this study
Official title: High Frame Rate Contrast Enhanced-ultrasound for the Assessment of Ischaemic Heart Disease
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.
Read the 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).
- Conditions
- Coronary Artery Disease
- Being tested
- Standard echocardiography, High frame rate echocardiography
- Keywords
- echocardiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard echocardiographyDiagnostic test
Patients will undergo standard echocardiography, with and without contrast
High frame rate echocardiographyOther
Following standard echocardiography, the test is repeated using high frame rate ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between HFR ultrasound and standard ultrasound.
Demonstration that there is at least 80% agreement between HFR ultrasound techniques and standard techniques. Expressed as as a percentage of the recorded images.
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Feb 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roxy Senior, MD, Principal investigator, LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850015
- Sponsor's protocol ID
- CRC/2018/001
- Acronym
- RUFUS-Heart
- Status last verified
- May 2025
- First submitted
- 30 Jan 2019
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Frame Rate Contrast Enhanced-ultrasound for the Assessment of Ischaemic Heart Disease
- ClinicalTrials.gov ID
- NCT03850015
- Acronym / sponsor ID
- RUFUS-Heart / CRC/2018/001
- Conditions
- Coronary Artery Disease
- Keywords
- echocardiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 25 patients will be recruited over 12 months. 5 of these patients will be at low high of having coronary artery disease and 20 at high risk of coronary artery disease. patients will be recruited from those referred for clinical stress stress echocardiography.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard echocardiographyPatients will undergo standard echocardiography, with and without contrast | Diagnostic test | – |
| High frame rate echocardiographyFollowing standard echocardiography, the test is repeated using high frame rate ultrasound | Other | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No. Individual data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roxy Senior, MD principal investigator
LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Howard, MSc (+442088692547, emma.howard16@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between HFR ultrasound and standard ultrasound. (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.