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

Recruiting

• Conditions: Subclinical hypothyroïdism; Acute Coronary Syndrome
• Interventions: Diagnostic Test: thyroid function tests; Diagnostic Test: cardiac enzymes; Diagnostic Test: ECG

• Registration Number: NCT06409520
• Lead Sponsor: Sohag University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-25
• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-07
• Last Update Submitted: 2024-05-07
• Study First Posted: 2024-05-10
• Last Update Posted: 2024-05-10
• Primary Completion: 2025-05
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group (2)	ECG	(control group) patients with acute coronary syndrome and normal thyroid function
Group (1)	thyroid function tests	patients with acute coronary syndrome and subclinical hypothyroidism
Group (1)	ECG	patients with acute coronary syndrome and subclinical hypothyroidism
Group (2)	cardiac enzymes	(control group) patients with acute coronary syndrome and normal thyroid function
Group (1)	cardiac enzymes	patients with acute coronary syndrome and subclinical hypothyroidism
Group (2)	thyroid function tests	(control group) patients with acute coronary syndrome and normal thyroid function

Primary Outcome Measures

Name	Time	Method
Short-term complications	1 year	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

Trial Locations

Locations (1)

Sohag university Hospital; 🇪🇬 Sohag, Egypt