Impact Of Subclinical Hypothyroidism On Short-Term Outcomes In Patients With Acute Coronary Syndrome In Sohag University Hospitals

Acute Coronary Syndrome Clinical Trial

Official title:

Impact Of Subclinical Hypothyroidism On Short-Term Outcomes In Patients With Acute Coronary Syndrome In Sohag University Hospitals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06409520
• Other study ID #: soh-Med-24-04-04MD
• Status: Recruiting
• Start date: April 25, 2024
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Sohag University
• Contact: Amr I Abd El-Haleem, assistant lecutrer
• Phone: 01014010393
• Email: amr_adam[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Hypothyroidism
• Subclinical hypothyroïdism
• Syndrome

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Egypt	Sohag university Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-term complications	events during hospitalisation will be documented, and patients will be followed up for 30 days. The documented inhospital events include cardiogenic shock, Ejection fraction less than 40%, Killip class more than one, new atrial fibrillation, sudden cardiac arrest, bradyarrhythmia necessitating pacing, major bleeding necessitating blood transfusion, and acute kidney injury while hospitalized	1 year