To assess the changes in cardiac function and the microcirculatory function in different thyroid states. We aim to identify how thyroid state affects changes in micro and macro hemodynamics.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Thyroid gland disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
changes in cardiac function (cardiac output and mean arterial bloodpressure)
and microcirculatory function (as measured with Cytocam) in different thyroid
states.
Secondary outcome
• Capillary refill time
• Skin-difference temperature gradient (Tskin-diff)
• Peripheral perfusion index (PI)
• Transthoracic cardiac ultrasound
• Heart rate
Background summary
Hypothyroidism is a common disorder affecting ~4.5% of the population. Despite
adequate restoration of biochemical euthyroidism (defined as normal levels of
Thyroid Stimulating Hormone (TSH) and thyroxine (T4)), a significant number of
patients have persistent symptoms such as fatigue; muscle aches and diminished
cognitive and psychological function. However, the cause of these persistent
symptoms is unknown.
Normal thyroid hormone levels are required to maintain normal cardiovascular
function. Important changes in cardiac structure and function have been
reported in patients with overt and subclinical hypothyroidism. Endothelial
dysfunction has also been reported in conduit arteries of patients with
clinical and subclinical hypothyroidism. The microcirculation is the main site
of oxygen delivery to tissue cells and is essential for the maintenance of
cellular life and function. The function of the organs is directly dependent on
the function of their respective microcirculation. The effects of thyroid
hormone deficiency on the microcirculation have not been assessed. The
hypothesis is that changes in microcirculation and macrocirculation may well
explain the variable symptoms in patients with biochemical euthyroidism.
Study objective
To assess the changes in cardiac function and the microcirculatory function in
different thyroid states. We aim to identify how thyroid state affects changes
in micro and macro hemodynamics.
Study design
Single centre, observational cohort study. Patients with differentiated thyroid
cancer are treated with radioactive iodine as part of the cancer treatment
after thyroidectomy and in case of residual or recurrent disease. These
patients are subject to hypothyroidism (before I-131 therapy) followed by
subclinical hyperthyroidism after reinitiating thyroid hormone. Therefore,
patients with differentiated thyroid cancer provide an excellent model to study
the consequences of variations in thyroid state. All patients who will be
treated with radioactive iodine, will be approached for cardiac output
measurement, cardiac ultrasound, assessment of the microcirculation and a
12-lead electrocardiogram.
Study burden and risks
Microcirculation and cardiac output assessment are non-invasive procedures and
there are no risks associated with these monitoring devices. The assessment
will take about 30 minutes and will take place during the regular clinical
follow-up. The risks associated with participation are negligible. Subjects
will be compensated with a VVV-voucher of 100 Euro per visit.
dr. molewaterplein 50
Rotterdam 3015 GE
NL
dr. molewaterplein 50
Rotterdam 3015 GE
NL
Listed location countries
Age
Inclusion criteria
Patients with differentiated thyroid carcinoma who have to receive a treatment with radioactive iodine.
Has the capacity to understand and willingness to sign an informed consent form
Aged 18-80 years
Exclusion criteria
* Other malignancy
* Clinically relevant active systemic disease (such as autoimmune or infectious diseases)
* Pregnancy
* Heart failure (New York Heart Association (NYHA) classes II, III or IV)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL46357.078.14 |