'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 |
| Protocol serial number | 7355 |
| Sponsor | Imperial College Healthcare NHS Trust (UK) |
| Funder | British Heart Foundation (BHF) (UK) |
- Submission date
- 18/06/2010
- Registration date
- 18/06/2010
- Last edited
- 27/08/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Michaela Moraldo
Scientific
Scientific
St Mary's Hospital
International Centre for Circulatory Health
Praed Street
London
W2 1NY
United Kingdom
| m.moraldo@imperial.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre non-randomised interventional diagnosis trial |
| Secondary study design | Non randomised controlled trial |
| 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(s) |
Effective regurgitant orifice area (EROA), measured during 40 minutes of acquisition |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 23/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St Mary's Hospital
London
W2 1NY
United Kingdom
W2 1NY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2013 | Yes | No |
