Atherosclerosis, subclinical hypothyroidism Circulatory System Atherosclerosis
Conditions
Interventions
1. L-thyroxine, beginning at 0.0125 and gradually increased to achieve target TSH level greater than 0.4 and less than 2 and FT4 greater than 4 and less than 25 pmol/L for 18 months
2. Matching placeb
Sponsors
Robarts Research Institute (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients: 1. With subclinical hypothyroidism, defined as a TSH of 3 to 10 mU/L, and a normal serum free thyroxine level (FT4 11 to 25 pmol/L), and 2. Measurable plaque in the carotid arteries 3. Aged greater than or equal to 45 years
Exclusion criteria
Exclusion criteria: 1. Unwilling to give informed consent 2. History of atrial fibrillation 3. Unstable angina, or angina requiring nitroglycerine as often as once a month 4. Unlikely to adhere to the protocol 5. Unlikely to survive 18 months because of severe illness such as cancer 6. At risk of pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of progression of carotid plaque volume (mm^3) measured by 3-D ultrasound at baseline and 18 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intima-media thickness (IMT), measured at baseline and 18 months 2. Weight, waist circumference, measured every 6 months 3. Insulin resistance by Homeostasis Model Assessment (HOMA), homocysteine, lipids, measured at baseline and 19 months | — |
Countries
Canada
Outcome results
None listed