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| [ ...Back to search results ] | [ Print-friendly version ] |
| Effect of L-thyroxine on progression of Carotid Atherosclerosis in Subclinical Hypothyroidism |
| ISRCTN | ISRCTN64455739 |
| ClinicalTrials.gov identifier | |
| Public title | Effect of L-thyroxine on progression of Carotid Atherosclerosis in Subclinical Hypothyroidism |
| Scientific title | Effect of L-thyroxine on progression of Carotid Atherosclerosis in Subclinical Hypothyroidism: a single centre, randomised, two-arm parallel, placebo-controlled drug intervention |
| Acronym | T4CASH |
| Serial number at source | MCT-79197 |
| Study hypothesis |
Primary hypothesis:
That treatment of patients with subclinical hypothyroidism with L-thyroxine to achieve a target thyroid stimulating hormone (TSH) less than 2 and greater than 0.4 mIU/L and free thyroxine (FT4) greater than 4 and less than 25 pmol/L, will slow progression of carotid plaque volume and carotid intima-media thickness (IMT), compared to placebo. Secondary hypotheses: That treatment with L-thyroxine will improve control of plasma lipids and homocysteine, and reduce levels of C-reactive protein, weight, waist circumference and insulin resistance. Please note that as of 04/03/2009 the anticipated end date in this record was amended; the previous date at the time of registration was: Initial anticipated end date: 31/07/2007 |
| Lay summary | |
| Ethics approval | Research Ethics Board of the University of Western Ontario gave approval on the 24th June 2004 (ref: 10458). |
| Study design | Single centre, randomised, double blind (participant, investigator, caregiver, outcome assessor and data analyst), two-arm parallel, placebo-controlled drug intervention |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Atherosclerosis, subclinical hypothyroidism |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/07/2006 |
| Anticipated end date | 31/07/2010 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 254 |
| 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 placebo, with dummy dose adjustments for 18 months Contact for public queries: Tisha Mabb Lab Manager Stroke Prevention & Atherosclerosis Research Centre (SPARC) Robarts Research Institute Siebens-Drake Research Bldg. 1400 Western Rd London, Ontario N6G 2V2 Canada Email: tisha@robarts.ca |
| Primary outcome measure(s) | Rate of progression of carotid plaque volume (mm^3) measured by 3-D ultrasound at baseline and 18 months. |
| Secondary outcome measure(s) |
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 |
| Sources of funding | Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-79197) |
| Trial website | |
| Publications | |
| Contact name | Dr John David Spence |
| Address |
Stroke Prevention & Atherosclerosis Research Centre (SPARC)
Robarts Research Institute Siebens-Drake Research Bldg. 1400 Western Rd |
| City/town | London, Ontario |
| Zip/Postcode | N6G 2V2 |
| Country | Canada |
| Tel | +1 519 663 3113 |
| Fax | +1 519 663 3018 |
| dspence@robarts.ca | |
| Sponsor | Robarts Research Institute (Canada) |
| Address |
P.O. Box 5015
100 Perth Drive |
| City/town | London, Ontario |
| Zip/Postcode | N6A 5K8 |
| Country | Canada |
| Tel | +1 519 663 5777 |
| Fax | +1 519 661 3789 |
| lchapman@robarts.ca | |
| Sponsor website: | http://www.robarts.ca/home.php |
| Date applied | 21/05/2008 |
| Last edited | 04/03/2009 |
| Date ISRCTN assigned | 21/05/2008 |
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