Right ventricular function following coronary artery bypass graft

ISRCTN	ISRCTN29616922
DOI	https://doi.org/10.1186/ISRCTN29616922
Secondary identifying numbers	7353

Submission date: 28/05/2010
Registration date: 01/10/2010
Last edited: 30/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Beth Unsworth
Scientific

ICCH Building
59 North Wharf Road
London
W2 1LA
United Kingdom

Email	bunsworth77@hotmail.com

Study information

Study design	Single-centre observational case-controlled study
Primary study design	Observational
Secondary study design	Case-control study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Assessment of right ventricular function during and following cardiac surgery and evaluation of pericardial physiology in preserving right ventricular function
Study acronym	DRN 372
Study objectives	This is an observational study looking at the effects of cardiac surgery in right ventricular (RV) function in those patients referred for routine coronary artery bypass grafting (CABG) and aortic valve replacement (AVR) operations.
Ethics approval(s)	Sub-Committee of the REC, 19/01/2007, ref: 06/Q0403/163
Health condition(s) or problem(s) studied	Topic: Diabetes Research Network; Subtopic: Both; Disease: Cardiovascular disease
Intervention	Observational study using echocardiography to look at the immediate effects of cardiac surgery in RV function in those patients referred for routine CABG and AVR operations. Pre-, peri- and post-operative data collection. Study entry: registration only
Intervention type	Other
Primary outcome measure	Post-operative assessment of RV function; patients are last seen one month after surgery, but consented to return possibly at 6 months.
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/05/2009
Completion date	30/09/2010

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	Planned sample size: 100; UK sample size: 100
Key inclusion criteria	1. Patients with chronic systolic heart failure confirmed by transthoracic echo 2. Male and female, aged 51 - 91 years
Key exclusion criteria	1. Patients with severe lung disease 2. Any condition that would preclude them from lying comfortably on a couch for the duration of the study
Date of first enrolment	01/05/2009
Date of final enrolment	30/09/2010

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Imperial College Healthcare NHS Trust

London
W2 1LA
United Kingdom

Sponsor information

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

Funders

Funder type

Charity

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

Alternative name(s): the_bhf, The British Heart Foundation, BHF
Location: United Kingdom

Results and Publications

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

Editorial Notes

30/09/2016: No publications found, verifying study status with principal investigator.