Fourth Contrast Study: contrast study for patients undergoing diagnostic coronary angiography

ISRCTN ISRCTN16544658
DOI https://doi.org/10.1186/ISRCTN16544658
Secondary identifying numbers N0227115061
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
15/04/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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

Mr YKS Viswanath
Scientific

The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Phone +44 (0)1642 854863
Email yks.viswanath@stees.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Scientific titleFourth Contrast Study: contrast study for patients undergoing diagnostic coronary angiography
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAngiography
InterventionRandomised 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)NIOPAM®, Xenetix®
Primary outcome measureClinical outcome and adverse effects of the contrast agents.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/08/2002
Completion date30/09/2003

Eligibility

Participant type(s)Patient
Age groupOther
SexBoth
Target number of participants2000
Key inclusion criteria1. Patients admitted for cardiac catheterisation.
2. Approximately 2000 subjects.
3. No selection bias to gender or age group.
Key exclusion criteriaPregnant patients will be excluded, unless patient has life threatening condition.
Date of first enrolment01/08/2002
Date of final enrolment30/09/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

South Tees Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

15/04/2016: No publications found, study status unverified.