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

NCT ID: NCT06409520

Last Updated: 2024-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-25

Study Completion Date

2025-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Subclinical hypothyroïdism Acute Coronary Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group (1)

patients with acute coronary syndrome and subclinical hypothyroidism

thyroid function tests

Intervention Type 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.

cardiac enzymes

Intervention Type DIAGNOSTIC_TEST

troponine

ECG

Intervention Type DIAGNOSTIC_TEST

Electrocardiogram

Group (2)

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

thyroid function tests

Intervention Type 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.

cardiac enzymes

Intervention Type DIAGNOSTIC_TEST

troponine

ECG

Intervention Type DIAGNOSTIC_TEST

Electrocardiogram

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

cardiac enzymes

troponine

Intervention Type DIAGNOSTIC_TEST

ECG

Electrocardiogram

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sohag University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amr Ibrahim Abd El-haleem Adam

Assistant lecturer internal medicine sohag university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sohag university Hospital

Sohag, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amr I Abd El-Haleem, assistant lecutrer

Role: CONTACT

01014010393

lotfy H abo dahab, professor

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mgdy M Amin, professor

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 22273398 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29081800 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32031647 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23162099 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26248862 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

soh-Med-24-04-04MD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.