Relationship of Noninvasive Assessment of Central BP With 10 Years Atherosclerotic CVD in Subclinical Hypothyroidism

Relationship of Noninvasive Assessment of Central Blood Pressure With 10 Years Atherosclerotic Cardiovascular Disease in Subclinical Hypothyroidism

verify Relationship of noninvasive assessment of central arterial blood pressure with 10 years Atherosclerotic Cardiovascular disease (ASCVD) in Subclinical hypothyroidism

Study Overview

• Status: Not yet recruiting
• Conditions: Subclinical hypothyroïdism

Detailed Description

Subclinical hypothyroidism (SCH), characterized by elevated thyrotropin (TSH) levels with normal free thyroxine (T3,T4) concentrations, is a prevalent disorder affecting approximately 10% of the adult population. It has been increasingly recognized for its potential impact on cardiovascular health. A 10-year follow-up study highlighted a significant association between elevated serum TSH levels and increased cardiovascular (CV) risk, independent of conventional risk factors. And it demonstrated its association with hypercholesterolemia and atherosclerosis as the leading risk of CVD. Moreover, in a recent meta-analysis, subclinical hypothyroidism was shown actually be correlated with an increased risk of CVD and mortality.

Monitoring thyroid function underscores the potential importance of cardiovascular (CV) risk assessment, for patients with subclinical hypothyroidism (SCH). Incorporating thyroid function tests, such as TSH and free thyroxine (FT4) levels, alongside non-invasive central arterial blood pressure monitoring, provides a comprehensive understanding of a patient's CV risk. This integrated approach enables early identification and targeted interventions, ultimately improving patient outcomes and reducing the incidence of CVD among those with SCH.

One of the earliest functional changes underlying ASCVD is Arterial stiffening it reflects a variety of pathologies, including atherosclerosis. As an important determinant of cardiovascular health, arterial stiffness can contribute to increased blood pressure and reduces vessels' capacity to buffer the pulsatile flow when the heart contracts, which are significant risk factors for predicting ASCVD.

For continuous non-invasive central arterial blood pressure monitoring, the auscultatory method or The Oscillometric technique can be used. These methods provide valuable insights into the health of the central arteries, which are crucial in understanding the cardiovascular risk profile of patients with SCH.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Mona Abdelhameed, Master; Phone Number: +201015832556; Email: Mona.16266057@med.aun.edu.eg
• Study Contact Backup: Name: Sohair Mostafa, Prof; Phone Number: 01069347314; Email: soheir@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Full Personal history will include:

Demographic data age, sex, material status, smoking history, residence (rural, urban) ,presence of previous medical disease (DM ,HTN, cardiac ,renal disease).

Full medical history will include Duration of the disease, history of treatment intake ,history of autoimmune disease

Description

Inclusion Criteria:

• Age 18-70
• Both sex

Exclusion Criteria:

• Patients had thyroidectomy operation
• Patients with a history of encompassing acute coronary syndrome (ACS).
• Myocardial infarction (MI).
• Coronary heart disease (CHD).
• Cerebrovascular diseases or other arterial revascularization

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
patients with subclinical hypothyroidism admitted to internal medicine department.
healthy match individual .; healthy match individual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the extent to which subclinical hypothyroidism is associated with atherosclerotic cardiovascular disease	the extent to which subclinical hypothyroidism is associated with atherosclerotic cardiovascular disease	2025

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Mohamed Faisal, Doctor, Dr/ Mohamed Faisal El Adway

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): September 24, 2024
• Last Update Submitted That Met QC Criteria: September 21, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases; Hypothyroidism
• Other Study ID Numbers: Central BP and hypothyroidism

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No