Incidence of Atrial Fibrillation in Adults Aged = 65 Clinical Trial
— AF-StrokeOfficial title:
Eine Beobachtungsstudie Zur Erfassung Von (Asymptomatischem)Vorhofflimmern Mittels Eines Gelegenheitsscreenings älteren Menschen ab 65 Jahren
Verified date | April 2018 |
Source | RWTH Aachen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
Atrial fibrillation (AF) is the most common arrhythmia in Germany and is associated with an
increased risk of thromboembolic stroke. The risk to suffer from AF increases with age. Early
detection of AF and anticoagulation seem the most effective way of preventing ischaemic
stroke in patients at risk. The guidelines of the European Society of Cardiology recommend
opportunistic screening for AF by pulse check at each general practitioner visit for all
patients aged 65 years or older.
The objective of this study was to test whether an opportunistic AF screening with a
hand-held diagnostic tool in a German pharmacy setting is useful in detecting unknown AF
among people in the age of 65 and older. Besides a pulse palpation with a hand-held ECG-stick
the screening in the pharmacies also includes a questionnaire related to demographics and
medical history of the subject as well as several questions concerning the stroke risk
stratification (CHA₂DS₂-VASc). Every subject with a positive test result (indication on AF)
is insistently asked to make an appointment with his or her general practitioner. The subject
receives an information letter for his or her general practitioner that adverts to the
positive screening result and the necessity of further diagnostic Investigation.
In order to assess the incidence of unknown AF as well as accomplish the secondary objectives
of this study, two follow-ups by means of telephone interviews are performed. First, all
subjects with a positive test result are called 8 weeks after the screening in the pharmacies
was conducted. The subject is asked several questions concerning personal data/demographics,
the stroke risk (CHA₂DS₂-VASc), the medical history regarding to dyspnea and stroke, the
bleeding risk (HAS-Bled), the medication, the device, diagnostic, the therapy, the
Intervention and the mace. 12 months after the screening in the pharmacies was performed, all
participating subjects were called. The list of questions is similar to the one that is used
during the first telephone interviews after eight weeks.
Status | Completed |
Enrollment | 7606 |
Est. completion date | August 22, 2018 |
Est. primary completion date | August 22, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility |
Inclusion Criteria: - At least 65 years or older - Signed informed consent - Signed subject information Exclusion Criteria: - Insufficient language skills - Limited cognitive abilities - Limited physical abilities (i.e. tremor) |
Country | Name | City | State |
---|---|---|---|
Germany | Uniklinium RWTH Aachen | Aachen |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University | Apothekerverband Aachen e.V., Pfizer |
Germany,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of newly detected atrial fibrillation in adults from the age of 65 by means of an opportunistic screening with an ECG hand-held diagnostic tool in a pharmacy setting | The data is going to be collected in a screening period of two weeks in an urban pharmacy setting and a screening period of two weeks of data collection in a more rural pharmacy setting | 12 months | |
Secondary | The subject's behavior change regarding diagnosis and therapy from the ECG measurement at pharmacy at 8 weeks and 12 months. | The subject's behavior change is measured by means of a questionnaire, compiled by the research team. The questionnaire is used during the telephone interviews 8 eight weeks and 12 months. The questionnaire includes questions related to personal data/demographics, the stroke risk (CHA2DS2-VASc), the medical history regarding to dyspnea and stroke, the bleeding risk (HAS-Bled), the medication, the device, diagnostic, the therapy, the Intervention and the mace. | 8 weeks and 12 Months | |
Secondary | Identification and description of new therapeutic measures. | 12 Months |