'AQURO', a new, potentially automatable approach for quatifying mitral regurgitation: technology development and validation through collaboration between cardiovascular science and bioengineering

ISRCTN	ISRCTN14627513
DOI	https://doi.org/10.1186/ISRCTN14627513
Secondary identifying numbers	7355

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Miss Michaela Moraldo
Scientific

St Mary's Hospital
International Centre for Circulatory Health
Praed Street
London
W2 1NY
United Kingdom

Email	m.moraldo@imperial.ac.uk

Study design	Single-centre non-randomised interventional diagnosis trial
Primary study design	Interventional
Secondary study design	Non randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title
Study acronym	DRN 373 (AQURO)
Study objectives	Stable subjects with mitral regurgitation previously diagnosed on echocardiography will be recruited from the outpatient service of Imperial College Healthcare NHS Trust. We will follow the standard British Society of Echocardiography protocol, and then add additional views. The standard protocol involves ultrasound recordings in different positions around the heart. Each complete echocardiography appointment will take approximately 40 minutes. All calculations made from the recorded images will occur later, after the patient has left.
Ethics approval(s)	MREC approved (ref: 08/H0707/71)
Health condition(s) or problem(s) studied	Topic: Diabetes Research Network; Subtopic: Type 2; Disease: Cardiovascular disease
Intervention	Patients are recruited and ultrasound scans are performed for about 40 minutes to be analysed and compared with the standard technique. Study entry: registration only
Intervention type	Other
Primary outcome measure	Effective regurgitant orifice area (EROA), measured during 40 minutes of acquisition
Secondary outcome measures	Not provided at time of registration
Overall study start date	23/03/2009
Completion date	23/03/2012

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Planned sample size: 50; UK sample size: 50
Key inclusion criteria	Stable subjects with mitral regurgitation previously diagnosed on echocardiography
Key exclusion criteria	1. Atrial fibrillation 2. Moderate or severe disease of tricuspid or pulmonary valves 3. Any aortic valve disease graded mild or higher 4. Prosthetic aortic valve and body habitus or coexistent disease that precludes satisfactory imaging quality
Date of first enrolment	23/03/2009
Date of final enrolment	23/03/2012

St Mary's Hospital

London
W2 1NY
United Kingdom

Imperial College Healthcare NHS Trust (UK)
Hospital/treatment centre

International Centre for Circulatory Health
59 North Wharf Road
London
W2 1LA
England
United Kingdom

Website	http://www.imperial.nhs.uk/
"ROR"	https://ror.org/056ffv270

Charity

British Heart Foundation (BHF) (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2013		Yes	No