| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN66874446 |
| Date ISRCTN assigned | 08/08/2006 |
| Local reference number(s) | G0500783 |
| Public title | UK Trial of Radioiodine Intervention in Subclinical Hyperthyroidism |
| Scientific title |
|
| Acronym | TRISH |
| Disease/condition/study domain | Subclinical hyperthyroidism |
| Study hypothesis | Radioiodine treatment for sustained subclinical hyperthyroidism will not reduce circulatory endpoints in the elderly. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Approval gained from the Newcastle and North Tyneside Research Ethics Committee (reference number: 06/Q0905/112). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Over 65 years of age
2. Sustained subclinical hyperthyroidism (undetectable Thyroid Stimulating Hormome [TSH], normal free thyroid
hormones) for greater than three months |
| Participants - exclusion criteria | 1. Patient currently has or has ever had Atrial Fibrillation (AF)
2. Certain drug usage
3. Pituitary, severe renal or hepatic disease
4. Unstable coronary disease |
| Patient information material |
|
| Anticipated start date | 01/10/2006 |
| Anticipated end date | 30/09/2015 |
| Status of trial | Ongoing |
| Target number of participants | 780 |
| Interventions | Radioiodine treatment versus usual care. |
| Primary outcome measure(s) | Composite circulatory mortality |
| Secondary outcome measure(s) | 1. All cause mortality
2. Atrial fibrillation
3. Progression to overt
hyperthyroidism
4. Hip and vertebral fractures
5. MMTS |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Newcastle upon Tyne Hospitals NHS Trust (UK) |
| Sponsor details | Research and Development Department
Clinical Research Facility
Leazes Wing, 4th Floor
Royal Victoria Infirmary
Newcastle upon Tyne
United Kingdom
NE1 4LP |
| Contact name | Dr Simon Pearce |
| Contact details | School of Clinical Medical Sciences
University of Newcastle
Newcastle upon Tyne
United Kingdom
NE2 4HH |
| Contact email | s.h.s.pearce@ncl.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN66874446 |
| Date last extracted from ISRCTN register | 17/04/2008 |
