Condition category
Circulatory System
Date applied
18/06/2010
Date assigned
18/06/2010
Last edited
27/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.imperial.nhs.uk/

Funders

Funder type

Charity

Funder name

British Heart Foundation (BHF) (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/22217482

Publication citations

  1. 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.

Additional files

Editorial Notes