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

May 7, 2024 updated by: Amr Ibrahim Abd El-haleem Adam, Sohag University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: lotfy H abo dahab, professor

Study Locations

  • Egypt
      • Sohag, Egypt, Sohag
        • Recruiting
        • Sohag university Hospital
        • Contact:
          • Mgdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group (1)
patients with acute coronary syndrome and subclinical hypothyroidism
Diagnostic test: ECG
Electrocardiogram
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.
Diagnostic test: cardiac enzymes
troponine
Group (2)
(control group) patients with acute coronary syndrome and normal thyroid function
Diagnostic test: ECG
Electrocardiogram
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.
Diagnostic test: cardiac enzymes
troponine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-term complications
Time Frame: 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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

May 10, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-Med-24-04-04MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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