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Preliminary analyses of data indicated study should be terminated for futility
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyperthyroid patients | Patients with hyperthyroidism admitted for treatment with radioiodine or antithyroid drugs |
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| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of asymptomatic (silent) atrial fibrillation in hyperthyroid patients | 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. | Upon inclusion and 2 weeks onwards |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of asymptomatic (silent) atrial fibrillation in patients treated for hyperthyroidism. | 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. | Between 12 and 14 weeks after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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We will screen all patients residing in the extended region around Stockholm, Sweden who have been referred and admitted to the Radiumhemmet clinic for investigation (and usually treatment) with radioiodine. As of February 2016, we will also include patients referred for treatment with antithyroid drugs at the endocrinology clinics of 1) Sahlgrenska University Hospital, Gothemburg Sweden, 2) Karolinska University Hospital, Stockholm, Sweden, 3) Danderyds Hospital, Stockholm, Sweden
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| Name | Affiliation | Role |
|---|---|---|
| MÃ¥rten Rosenqvist, Prof | Karolinska Institutet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicine Clinic, Sahlgrenska University Hospital | Gothemburg | 41345 | Sweden | |||
| Endocrinology Clinik, Karolinska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15302638 | Background | Frost L, Vestergaard P, Mosekilde L. Hyperthyroidism and risk of atrial fibrillation or flutter: a population-based study. Arch Intern Med. 2004 Aug 9-23;164(15):1675-8. doi: 10.1001/archinte.164.15.1675. | |
| 17207725 | Background | Osman F, Franklyn JA, Holder RL, Sheppard MC, Gammage MD. Cardiovascular manifestations of hyperthyroidism before and after antithyroid therapy: a matched case-control study. J Am Coll Cardiol. 2007 Jan 2;49(1):71-81. doi: 10.1016/j.jacc.2006.08.042. Epub 2006 Dec 13. |
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| ID | Term |
|---|---|
| D006980 | Hyperthyroidism |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
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| Prevalence of risk factors for stroke in patients with atrial fibrillation | Risk factors for stroke in atrial fibrillation according to the CHADS-VASc-scoring system. | Momentary (day 1, upon inclusion) |
| Stockholm |
| 17176 |
| Sweden |
| Medicine Clinic, Danderyds Hospital | Stockholm | 18288 | Sweden |
| 17941909 | Background | Metso S, Auvinen A, Salmi J, Huhtala H, Jaatinen P. Increased long-term cardiovascular morbidity among patients treated with radioactive iodine for hyperthyroidism. Clin Endocrinol (Oxf). 2008 Mar;68(3):450-7. doi: 10.1111/j.1365-2265.2007.03064.x. Epub 2007 Oct 17. |
| 22922413 | Background | Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available. |
| D002318 |
| Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |