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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06409520
Enrollment
200
Registered
2024-05-10
Start date
2024-04-25
Completion date
2025-08-31
Last updated
2024-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subclinical hypothyroïdism, 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.

Interventions

DIAGNOSTIC_TESTthyroid 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.

DIAGNOSTIC_TESTcardiac enzymes

troponine

DIAGNOSTIC_TESTECG

Electrocardiogram

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Short-term complications1 yearevents 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

Countries

Egypt

Contacts

Primary ContactAmr I Abd El-Haleem, assistant lecutrer
amr_adam@med.sohag.edu.eg01014010393
Backup Contactlotfy H abo dahab, professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026