High Frame Rate Ultrasound in Heart Disease Assessment

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT03850015
• Lead Sponsor: London North West Healthcare NHS Trust

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).

Study Timeline

• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Study Start: 2022-02-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-23
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Agreement between HFR ultrasound and standard ultrasound.	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.

Trial Locations

Locations (1)

London North West University Healthcare NHS Trust; 🇬🇧 Harrow, Middx, United Kingdom