Subclinical hypothyroïdismNCT06607978
Relationship of Noninvasive Assessment of Central BP With 10 Years Atherosclerotic CVD in Subclinical Hypothyroidism
An observational study of Subclinical hypothyroïdism, run by Assiut University.
Trial summary
verify Relationship of noninvasive assessment of central arterial blood pressure with 10 years Atherosclerotic Cardiovascular disease (ASCVD) in Subclinical hypothyroidism Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Subclinical hypothyroïdism
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Age 18-70
- Both sex
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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.
- Conditions
- Subclinical hypothyroïdism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with subclinical hypothyroidism admitted to internal medicine department. | patients with subclinical hypothyroidism admitted to internal medicine department. | |
| healthy match individual . | healthy match individual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical hypothyroïdismStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Abdelhameed Saber, Assiut University
- Investigators
- Mohamed Faisal, Doctor, Study director, Dr/ Mohamed Faisal El Adway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607978
- Sponsor's protocol ID
- Central BP and hypothyroidism
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship of Noninvasive Assessment of Central Blood Pressure With 10 Years Atherosclerotic Cardiovascular Disease in Subclinical Hypothyroidism
- ClinicalTrials.gov ID
- NCT06607978
- Acronym / sponsor ID
- Central BP and hypothyroidism
- Conditions
- Subclinical hypothyroïdism
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
verify Relationship of noninvasive assessment of central arterial blood pressure with 10 years Atherosclerotic Cardiovascular disease (ASCVD) in Subclinical hypothyroidism
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with subclinical hypothyroidism admitted to internal medicine department. | – | –patients with subclinical hypothyroidism admitted to internal medicine department. |
| healthy match individual . | – | –healthy match individual |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Age 18-70
- Both sex
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the extent to which subclinical hypothyroidism is associated with atherosclerotic cardiovascular disease
Time frame: 2025
the extent to which subclinical hypothyroidism is associated with atherosclerotic cardiovascular disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Faisal, Doctor study director
Dr/ Mohamed Faisal El Adway
Questions about this trial
What is this clinical trial studying?
An observational study of Subclinical hypothyroïdism, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mona Abdelhameed, Master (+201015832556, Mona.16266057@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the extent to which subclinical hypothyroidism is associated with atherosclerotic cardiovascular disease (time frame: 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.