Contact information
Type
Scientific
Primary contact
Mr Unnikrishnan Nair
ORCID ID
Contact details
Cardiothoracic Surgery Department
Yorkshire Heart Centre
D Floor
Jubilee Building
Great George Street
Leeds
LS1 3EX
United Kingdom
+44 (0)113 392 5792
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0436176306
Study information
Scientific title
Internal mammary artery harvest with papaverine vs saline infiltration
Acronym
Study hypothesis
To see whether infiltrating papaverine into endothoracic fascia while harvesting compared to saline as reported in literature makes any difference in terms of spasm, size and flow difference in the mammary conduit.
Ethics approval
Leeds East Ethics Committee, ref 05/Q1206/185
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Surgery: Coronary artery bypass graft (CABG)
Intervention
Internal thoracic artery (IMA) harvest with papaverine vs normal saline infiltration into endothoracic fascia
Intervention type
Drug
Phase
Not Applicable
Drug names
Papaverine
Primary outcome measures
To see the difference in quality of mammary artery conduit with two different methods of harvesting (quality of the mammary artery that includes the spasm, flow and appearances).
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/02/2006
Overall trial end date
01/07/2008
Reason abandoned
Eligibility
Participant inclusion criteria
All patients having coronary artery bypass surgery where artery behind the breast bone is used will be invited to take part.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50 with 25 in each group
Participant exclusion criteria
1. Patients not willing to participate
2. Internal Mammary Artery (IMA) not used
Recruitment start date
01/02/2006
Recruitment end date
01/07/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Leeds Teaching Hospitals NHS Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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