Clinical trial NCT06409520: Impact Of Subclinical Hypothyroidism On Short-Term Outcomes In Patients With Acute Coronary Syndrome In Sohag University Hospitals
Official title: Impact Of Subclinical Hypothyroidism On Short-Term Outcomes In Patients With Acute Coronary Syndrome In Sohag University Hospitals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Subclinical hypothyroïdism
Acute Coronary Syndrome
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (age ≥18 years) diagnosed with acute coronary syndrome

Brief summary: Introduction:

Subclinical hypothyroidism (SCH) is defined biochemically as a normal serum free thyroxine (T4) level in the presence of an increased serum thyroid stimulating hormone (TSH) concentration.(1) Its prevalence ranges from 4 to 15 percent and is higher in females and increasing age.(2) Overt hypothyroidism was associated with accelerated atherosclerosis and an increased risk of cardiovascular abnormalities. (3) Some studies have reported a higher atherosclerotic cardiovascular disease risk in patients with SCH. (5-8) Elevated TSH levels were observed to be associated with higher cholesterol levels.(9) Higher mortality was also reported in some studies (6,10) especially with TSH ≥ 10.0 mIU/L, in contrast to other studies.(11,12) Heart failure events and myocardial infarction have been reported to be higher.(13,14) These findings in SCH patients could be explained by mitochondrial oxidative stress due to elevated inflammatory markers, hypercoagulability, endothelial dysfunction, insulin resistance, increased vascular resistance and left ventricular diastolic and systolic dysfunction.(3,15,16) As is the case with overt hypothyroidism, SCH was observed to be associated with elevated peripheral vascular resistance and diastolic dysfunction.(17) There are a few studies evaluating the effects of subclinical hypothyroidism on the outcomes of acute coronary syndrome patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients (age ≥18 years) diagnosed with acute coronary syndrome

Exclusion Criteria:

1. Patients with overt hypothyroidism or hyperthyroidism.
2. Pregnant and lactating females
3. Patients with severe comorbid conditions e.g. Malignancy decompensated liver diseases or end stage kidney diseases.
4. Patients with a history of taking medications affecting thyroid function

Primary outcomes:
measure: Short-term complications
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Cooper DS, Biondi B. Subclinical thyroid disease. Lancet. 2012 Mar 24;379(9821):1142-54. doi: 10.1016/S0140-6736(11)60276-6. Epub 2012 Jan 23.
citation: Sun J, Yao L, Fang Y, Yang R, Chen Y, Yang K, Tian L. Relationship between Subclinical Thyroid Dysfunction and the Risk of Cardiovascular Outcomes: A Systematic Review and Meta-Analysis of Prospective Cohort Studies. Int J Endocrinol. 2017;2017:8130796. doi: 10.1155/2017/8130796. Epub 2017 Aug 31.
citation: Inoue K, Ritz B, Brent GA, Ebrahimi R, Rhee CM, Leung AM. Association of Subclinical Hypothyroidism and Cardiovascular Disease With Mortality. JAMA Netw Open. 2020 Feb 5;3(2):e1920745. doi: 10.1001/jamanetworkopen.2019.20745.
citation: Hyland KA, Arnold AM, Lee JS, Cappola AR. Persistent subclinical hypothyroidism and cardiovascular risk in the elderly: the cardiovascular health study. J Clin Endocrinol Metab. 2013 Feb;98(2):533-40. doi: 10.1210/jc.2012-2180. Epub 2012 Nov 16.
citation: Suh S, Kim DK. Subclinical Hypothyroidism and Cardiovascular Disease. Endocrinol Metab (Seoul). 2015 Sep;30(3):246-51. doi: 10.3803/EnM.2015.30.3.246. Epub 2015 Aug 4.