Condition category
Surgery
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
15/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

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