Thumb-ECG Ambulant Screening for Atrial Fibrillation in Patients Treated for Hyperthyroidism (TAMBOURINE) (TAMBOURINE)
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.
- 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Thumb-ECG Ambulant Screening for Atrial Fibrillation in Patients Treated for Hyperthyroidism (TAMBOURINE)|
- Prevalence of asymptomatic (silent) atrial fibrillation in hyperthyroid patients [ Time Frame: Upon inclusion and 2 weeks onwards ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]Risk factors for stroke in atrial fibrillation according to the CHADS-VASc-scoring system.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||November 2018 (Final data collection date for primary outcome measure)|
Patients with hyperthyroidism admitted for treatment with radioiodine or antithyroid drugs
Please refer to this study by its ClinicalTrials.gov identifier: NCT01945229
|Contact: Peter Giesecke, M.D.||+46 70 768 43 firstname.lastname@example.org|
|Medicine Clinic, Sahlgrenska University Hospital||Not yet recruiting|
|Gothemburg, Sweden, 41345|
|Contact: Helena Filipsson, MD +46 70 583 33 98 email@example.com|
|Endocrinology Clinik, Karolinska University Hospital||Recruiting|
|Stockholm, Sweden, 17176|
|Contact: Sergiu Catrina, MD +46 8 517 70 000 firstname.lastname@example.org|
|Principal Investigator: Peter Giesecke, M.D.|
|Sub-Investigator: Sergiu Catrina, M.D.|
|Medicine Clinic, Danderyds Hospital||Not yet recruiting|
|Stockholm, Sweden, 18288|
|Contact: Stelios Karayiannides, MD +46 8 123 50 00 email@example.com|
|Study Chair:||Mårten Rosenqvist, Prof||Karolinska Institutet|