High Frame Rate Ultrasound in Heart Disease Assessment

NCT ID: NCT03850015

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-09-30

Brief Summary

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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

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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

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Coronary Artery Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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Standard echocardiography

Patients will undergo standard echocardiography, with and without contrast

Intervention Type DIAGNOSTIC_TEST

High frame rate echocardiography

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London North West Healthcare NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roxy Senior, MD

Role: PRINCIPAL_INVESTIGATOR

LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST

Locations

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London North West University Healthcare NHS Trust

Harrow, Middx, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Emma Howard, MSc

Role: CONTACT

+442088692547

Lasha Gvinianidze, MD

Role: CONTACT

+442088692547

Facility Contacts

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Sunder Chita

Role: primary

Nana Theodorou

Role: backup

Other Identifiers

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CRC/2018/001

Identifier Type: -

Identifier Source: org_study_id

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