Contact information
Type
Scientific
Primary contact
Miss Michaela Moraldo
ORCID ID
Contact details
St Mary's Hospital
International Centre for Circulatory Health
Praed Street
London
W2 1NY
United Kingdom
m.moraldo@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7355
Study information
Scientific title
Acronym
DRN 373 (AQURO)
Study hypothesis
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
MREC approved (ref: 08/H0707/71)
Study design
Single-centre non-randomised interventional diagnosis trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measure
Effective regurgitant orifice area (EROA), measured during 40 minutes of acquisition
Secondary outcome measures
Not provided at time of registration
Overall trial start date
23/03/2009
Overall trial end date
23/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Stable subjects with mitral regurgitation previously diagnosed on echocardiography
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Planned sample size: 50; UK sample size: 50
Participant 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
Recruitment start date
23/03/2009
Recruitment end date
23/03/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Mary's Hospital
London
W2 1NY
United Kingdom
Sponsor information
Organisation
Imperial College Healthcare NHS Trust (UK)
Sponsor details
International Centre for Circulatory Health
59 North Wharf Road
London
W2 1LA
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
British Heart Foundation (BHF) (UK)
Alternative name(s)
BHF
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22217482
Publication citations
-
Results
Moraldo M, Bergamini C, Malaweera AS, Dhutia NM, Pabari PA, Willson K, Baruah R, Manisty C, Davies JE, Xu XY, Hughes AD, Francis DP, A novel fully automated method for mitral regurgitant orifice area quantification., Int. J. Cardiol., 2013, 166, 3, 688-695, doi: 10.1016/j.ijcard.2011.11.104.