Thumb-ECG Ambulant Screening for Atrial Fibrillation in Patients Treated for Hyperthyroidism (TAMBOURINE) (TAMBOURINE)
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| ClinicalTrials.gov Identifier: NCT01945229 |
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Recruitment Status :
Terminated
(Preliminary analyses of data indicated study should be terminated for futility)
First Posted : September 18, 2013
Last Update Posted : September 4, 2020
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Background: Atrial fibrillation is a common heart rhythm disturbance affecting some 1-2% of the western population. It may cause symptoms such as irregular heartbeats, shortness of breath, and fatigue. It may also be asymptomatic (ie "silent atrial fibrillation). In some cases, atrial fibrillation is permanent whereas in others it is sporadic. Regardless of symptoms, there is an increased risk of stroke in some patients with this condition. Novel technologies are being developed to increase detection of silent atrial fibrillation, in order to find patients who might benefit from treatment with oral anticoagulants (blood-thinning medications) in order to reduce the risk of stroke. One of these technologies is thumb-ECG, a simple way for a patient to have his or her heart rhythm reliably analyzed at home.
Hyperthyroidism (sometimes referred to as "toxic goiter") is defined as an excessive production of thyroid hormone. It is known that hyperthyroidism may cause atrial fibrillation in about 8% of cases.
Objective: To provide thumb-ECG-monitors to hyperthyroid patients before and after treating their hormonal disturbance, in order to find episodes of silent atrial fibrillation.
Design: Prospective observational study.
Hypotheses:
- Primary hypothesis: Silent atrial fibrillation is at least as common as overt atrial fibrillation in hyperthyroid patients.
- Secondary hypothesis nr 1: Atrial fibrillation continues to be more prevalent compared to the normal population even after hyperthyroidism is treated.
- Secondary hypothesis nr 2: The majority of patients with hyperthyroidism and atrial fibrillation are at increased risk of stroke and should be considered for treatment with oral anticoagulants.
| Condition or disease |
|---|
| Hyperthyroidism Atrial Fibrillation |
| Study Type : | Observational |
| Actual Enrollment : | 110 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Thumb-ECG Ambulant Screening for Atrial Fibrillation in Patients Treated for Hyperthyroidism (TAMBOURINE) |
| Study Start Date : | February 2014 |
| Actual Primary Completion Date : | August 2020 |
| Actual Study Completion Date : | August 2020 |
| Group/Cohort |
|---|
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Hyperthyroid patients
Patients with hyperthyroidism admitted for treatment with radioiodine or antithyroid drugs
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- Prevalence of asymptomatic (silent) atrial fibrillation in hyperthyroid patients [ Time Frame: Upon inclusion and 2 weeks onwards ]Upon inclusion, each patient will receive a thumb-ECG-monitor to take home. He/she will register his/her heart rhythm twice daily, and can also register at will upon symptoms. This will continue for 2 weeks, after which the monitor is returned.
- Prevalence of asymptomatic (silent) atrial fibrillation in patients treated for hyperthyroidism. [ Time Frame: Between 12 and 14 weeks after inclusion ]When a patient comes back to the policlinic after hyperthyroidism treatment (typically 3 months later), the same procedure is performed as upon inclusion. Thumb-ECG-monitoring is performed during a 2-week period.
- Prevalence of risk factors for stroke in patients with atrial fibrillation [ Time Frame: Momentary (day 1, upon inclusion) ]Risk factors for stroke in atrial fibrillation according to the CHADS-VASc-scoring system.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patient is deemed suitable for treatment with radioiodine or antithyroid drugs
- Patient has a thyreotropin (TSH) value below 0,1 mIU/L, measured less than 2 weeks before inclusion
- Patient has a CHADS-VASc-score of 1 point or higher (excluding if 1 point is for female sex only)
- Patient gives written consent to participate in study
Exclusion Criteria:
- Patient has a previously known diagnosis of atrial fibrillation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945229
| Sweden | |
| Medicine Clinic, Sahlgrenska University Hospital | |
| Gothemburg, Sweden, 41345 | |
| Endocrinology Clinik, Karolinska University Hospital | |
| Stockholm, Sweden, 17176 | |
| Medicine Clinic, Danderyds Hospital | |
| Stockholm, Sweden, 18288 | |
| Study Chair: | Mårten Rosenqvist, Prof | Karolinska Institutet |
| Responsible Party: | Peter Giesecke, M.D, M.D., specialist internal medicine and cardiology, Karolinska Institutet |
| ClinicalTrials.gov Identifier: | NCT01945229 |
| Other Study ID Numbers: |
3/9 B |
| First Posted: | September 18, 2013 Key Record Dates |
| Last Update Posted: | September 4, 2020 |
| Last Verified: | September 2020 |
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Atrial Fibrillation Hyperthyroidism Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Thyroid Diseases Endocrine System Diseases |