Contact information
Type
Scientific
Primary contact
Dr Simon Pearce
ORCID ID
Contact details
School of Clinical Medical Sciences
University of Newcastle
Newcastle upon Tyne
NE2 4HH
United Kingdom
s.h.s.pearce@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G0500783
Study information
Scientific title
Acronym
TRISH
Study hypothesis
Radioiodine treatment for sustained subclinical hyperthyroidism will not reduce circulatory endpoints in the elderly.
Ethics approval
Approval gained from the Newcastle and North Tyneside Research Ethics Committee (reference number: 06/Q0905/112).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Subclinical hyperthyroidism
Intervention
Radioiodine treatment versus usual care.
Intervention type
Drug
Phase
Not Specified
Drug names
Radioiodine
Primary outcome measures
Composite circulatory mortality
Secondary outcome measures
1. All cause mortality
2. Atrial fibrillation
3. Progression to overt
hyperthyroidism
4. Hip and vertebral fractures
5. MMTS
Overall trial start date
01/10/2006
Overall trial end date
30/09/2015
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
780
Participant 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
Recruitment start date
01/10/2006
Recruitment end date
30/09/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Clinical Medical Sciences
Newcastle upon Tyne
NE2 4HH
United Kingdom
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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