High Frame Rate Ultrasound in Heart Disease Assessment

NCT03850015 | Recruiting

• 1 other identifier: CRC/2018/001
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

echocardiography

Outcome Measures

Primary Outcomes (1)

• 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.

  At 1 year

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.
• patient who has been assessed as at low risk of having coronary heart disease

You may not qualify if:

• 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

Sponsors & Collaborators

• London North West Healthcare NHS Trust: lead

Study Sites (1)

London North West University Healthcare NHS Trust

Harrow, Middx, HA1 3UJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Roxy Senior, MD

  LONDON NORTH WEST UNIVERSITY HEALTHCARE NHS TRUST

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Howard, MSc

CONTACT

+442088692547; emma.howard16@nhs.net

Lasha Gvinianidze, MD

CONTACT

+442088692547; lasha.gviniandze1@nhs.net

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: February 21, 2019
• Study Start: February 1, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)