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Thumb-ECG Ambulant Screening for Atrial Fibrillation in Patients Treated for Hyperthyroidism (TAMBOURINE)

NCT01945229 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2020-09-04

No results posted yet for this study

Summary

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.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Mårten Rosenqvist, Prof · Karolinska Institutet

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Sweden

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01945229 on ClinicalTrials.gov