Impact Of Subclinical Hypothyroidism On Short-Term Outcomes In Patients With Acute Coronary Syndrome In Sohag University Hospitals
NCT ID: NCT06409520
Last Updated: 2024-05-10
Study Results
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Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-04-25
2025-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group (1)
patients with acute coronary syndrome and subclinical hypothyroidism
thyroid function tests
(TSH, free T4) The normal ranges of thyroid function tests were 0.40-4.99 mIU/L for TSH and 0.7-1.8 ng/dL for free T4. The same testing method will performed on all samples from all patients.
cardiac enzymes
troponine
ECG
Electrocardiogram
Group (2)
(control group) patients with acute coronary syndrome and normal thyroid function
thyroid function tests
(TSH, free T4) The normal ranges of thyroid function tests were 0.40-4.99 mIU/L for TSH and 0.7-1.8 ng/dL for free T4. The same testing method will performed on all samples from all patients.
cardiac enzymes
troponine
ECG
Electrocardiogram
Interventions
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thyroid function tests
(TSH, free T4) The normal ranges of thyroid function tests were 0.40-4.99 mIU/L for TSH and 0.7-1.8 ng/dL for free T4. The same testing method will performed on all samples from all patients.
cardiac enzymes
troponine
ECG
Electrocardiogram
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Amr Ibrahim Abd El-haleem Adam
Assistant lecturer internal medicine sohag university
Locations
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Sohag university Hospital
Sohag, , Egypt
Countries
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Central Contacts
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lotfy H abo dahab, professor
Role: CONTACT
Facility Contacts
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Mgdy M Amin, professor
Role: primary
References
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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.
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.
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.
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.
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.
Other Identifiers
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soh-Med-24-04-04MD
Identifier Type: -
Identifier Source: org_study_id
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