Thyroid Clinical Trial
— TECHOfficial title:
Post Thyroidectomy Myocardial Function
Verified date | August 2021 |
Source | Aristotle University Of Thessaloniki |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Protocol Synopsis Protocol title: Post thyroidectomy myocardial function Purpose: Evaluation of the effects of total thyroidectomy on myocardial function Design: Prospective, single-center, cohort study Patient Population: Male or female subjects 18 years of age or older who are scheduled for total thyroidectomy No. of Subjects: 50 patients, estimated up to 12 months to enroll Duration of Treatment: Operation Duration of Follow-up: After discharge, the patients will be re-evaluated at three (3), six (6) and twelve (12) months in the outpatient clinic. Endpoints: To evaluate the changes in the myocardial function after the removal of the thyroid gland.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 13, 2018 |
Est. primary completion date | October 13, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient is over 18 years old - Patient scheduled for a non-emergency operation - Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures - No previous cardiologic history - Normal PTH values (no transient hypoparathyroidism) Exclusion Criteria: - Patient is underage ( under 18 years old) - Patient had a previous operation at the thyroid or parathyroids - Patient inability to participate in follow-up appointments - Patient is participating in another clinical trial which may affect this study's outcomes - Patient with TSH values outside the range of normal values - Pathologic Ca2+ , Vit D, P, PTH, pre- and post-operative values - Diabetes Mellitus, Hypertension, History of any heart, lung or systemic disease. |
Country | Name | City | State |
---|---|---|---|
Greece | AHEPA University General Hospital, Aristotle University of Thessaloniki | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Aristotle University Of Thessaloniki |
Greece,
Bengel FM, Nekolla SG, Ibrahim T, Weniger C, Ziegler SI, Schwaiger M. Effect of thyroid hormones on cardiac function, geometry, and oxidative metabolism assessed noninvasively by positron emission tomography and magnetic resonance imaging. J Clin Endocrinol Metab. 2000 May;85(5):1822-7. — View Citation
Polikar R, Burger AG, Scherrer U, Nicod P. The thyroid and the heart. Circulation. 1993 May;87(5):1435-41. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Echocardiographic Assessment of Changes in Myocardial Function at 3, 6 and 12 months after Thyroidectomy | They will be assessed at 3, 6 and 12 months after thyroidectomy. |
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