Contact information
Type
Scientific
Primary contact
Mr YKS Viswanath
ORCID ID
Contact details
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
+44 (0)1642 854863
yks.viswanath@stees.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0227115061
Study information
Scientific title
Fourth Contrast Study: contrast study for patients undergoing diagnostic coronary angiography
Acronym
Study hypothesis
To compare two contrast agents routinely used in the Cath Lab.
To assess the clinical outcomes and adverse effects of these two agents.
To assess the potential advantage of one over the other.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Condition
Angiography
Intervention
Randomised study of two commonly used contrast agents (NIOPAM and Xenetix). Reactions due to contrast reaction will be recorded in a data collection form which will form the basis for a computer database. Will abide by The Data Protection Act.
Intervention type
Drug
Phase
Not Specified
Drug names
NIOPAM®, Xenetix®
Primary outcome measures
Clinical outcome and adverse effects of the contrast agents.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2002
Overall trial end date
30/09/2003
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients admitted for cardiac catheterisation.
2. Approximately 2000 subjects.
3. No selection bias to gender or age group.
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
2000
Participant exclusion criteria
Pregnant patients will be excluded, unless patient has life threatening condition.
Recruitment start date
01/08/2002
Recruitment end date
30/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
South Tees Hospitals NHS Trust (UK)
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