Fourth Contrast Study: contrast study for patients undergoing diagnostic coronary angiography
| ISRCTN | ISRCTN16544658 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16544658 |
| Protocol serial number | N0227115061 |
| Sponsor | Department of Health (UK) |
| Funder | South Tees Hospitals NHS Trust (UK) |
- 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
Scientific
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
| Phone | +44 (0)1642 854863 |
|---|---|
| yks.viswanath@stees.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Fourth Contrast Study: contrast study for patients undergoing diagnostic coronary angiography |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | NIOPAM®, Xenetix® |
| Primary outcome measure(s) |
Clinical outcome and adverse effects of the contrast agents. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Target sample size at registration | 2000 |
| Key inclusion criteria | 1. Patients admitted for cardiac catheterisation. 2. Approximately 2000 subjects. 3. No selection bias to gender or age group. |
| Key exclusion criteria | Pregnant patients will be excluded, unless patient has life threatening condition. |
| Date of first enrolment | 01/08/2002 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
The James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
15/04/2016: No publications found, study status unverified.
