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

NCT06409520 | Recruiting

• 1 other identifier: soh-Med-24-04-04MD
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Subclinical hypothyroïdism; Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Group (1)

patients with acute coronary syndrome and subclinical hypothyroidism

Diagnostic Test: thyroid function tests; Diagnostic Test: cardiac enzymes; Diagnostic Test: ECG

Group (2)

(control group) patients with acute coronary syndrome and normal thyroid function

Diagnostic Test: thyroid function tests; Diagnostic Test: cardiac enzymes; Diagnostic Test: ECG

Interventions

thyroid function tests DIAGNOSTIC_TEST

(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.

Group (1); Group (2)

cardiac enzymes DIAGNOSTIC_TEST

troponine

Group (1); Group (2)

ECG DIAGNOSTIC_TEST

Electrocardiogram

Group (1); Group (2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university Hospital

Sohag, Sohag, Egypt

RECRUITING

Related 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.

  PMID: 22273398 BACKGROUND

• 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.

  PMID: 29081800 BACKGROUND

• 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.

  PMID: 32031647 BACKGROUND

• 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.

  PMID: 23162099 BACKGROUND

• 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.

  PMID: 26248862 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Thyroid Function Tests; Electrocardiography

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Endocrine; Diagnostic Techniques and Procedures; Diagnosis; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis

Central Study Contacts

Amr I Abd El-Haleem, assistant lecutrer

CONTACT

01014010393; amr_adam@med.sohag.edu.eg

lotfy H abo dahab, professor

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer internal medicine sohag university

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: April 25, 2024
• Primary Completion: May 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

EG (1)