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,
Chugh SS, Blackshear JL, Shen WK, Hammill SC, Gersh BJ. Epidemiology and natural history of atrial fibrillation: clinical implications. J Am Coll Cardiol. 2001 Feb;37(2):371-8. Review. — View Citation
European Heart Rhythm Association; European Association for Cardio-Thoracic Surgery, Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J. 2010 Oct;31(19):2369-429. doi: 10.1093/eurheartj/ehq278. Epub 2010 Aug 29. Erratum in: Eur Heart J. 2011 May;32(9):1172. — View Citation
Heeringa J, van der Kuip DA, Hofman A, Kors JA, van Herpen G, Stricker BH, Stijnen T, Lip GY, Witteman JC. Prevalence, incidence and lifetime risk of atrial fibrillation: the Rotterdam study. Eur Heart J. 2006 Apr;27(8):949-53. Epub 2006 Mar 9. — View Citation
Kaasenbrood F, Hollander M, Rutten FH, Gerhards LJ, Hoes AW, Tieleman RG. Yield of screening for atrial fibrillation in primary care with a hand-held, single-lead electrocardiogram device during influenza vaccination. Europace. 2016 Oct;18(10):1514-1520. Epub 2016 Feb 6. — View Citation
Lip GY, Frison L, Halperin JL, Lane DA. Comparative validation of a novel risk score for predicting bleeding risk in anticoagulated patients with atrial fibrillation: the HAS-BLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) score. J Am Coll Cardiol. 2011 Jan 11;57(2):173-80. doi: 10.1016/j.jacc.2010.09.024. Epub 2010 Nov 24. — View Citation
Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010 Feb;137(2):263-72. doi: 10.1378/chest.09-1584. Epub 2009 Sep 17. — View Citation
Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D'Agostino RB, Massaro JM, Beiser A, Wolf PA, Benjamin EJ. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004 Aug 31;110(9):1042-6. Epub 2004 Aug 16. — View Citation
Lowres N, Krass I, Neubeck L, Redfern J, McLachlan AJ, Bennett AA, Freedman SB. Atrial fibrillation screening in pharmacies using an iPhone ECG: a qualitative review of implementation. Int J Clin Pharm. 2015 Dec;37(6):1111-20. doi: 10.1007/s11096-015-0169-1. Epub 2015 Jul 23. — View Citation
Lowres N, Neubeck L, Redfern J, Freedman SB. Screening to identify unknown atrial fibrillation. A systematic review. Thromb Haemost. 2013 Aug;110(2):213-22. doi: 10.1160/TH13-02-0165. Epub 2013 Apr 18. Review. — View Citation
Paciaroni M, Agnelli G, Caso V, Venti M, Milia P, Silvestrelli G, Parnetti L, Biagini S. Atrial fibrillation in patients with first-ever stroke: frequency, antithrombotic treatment before the event and effect on clinical outcome. J Thromb Haemost. 2005 Jun;3(6):1218-23. Epub 2005 May 9. — View Citation
Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest. 2010 Nov;138(5):1093-100. doi: 10.1378/chest.10-0134. Epub 2010 Mar 18. — View Citation
Schnabel RB, Wilde S, Wild PS, Munzel T, Blankenberg S. Atrial fibrillation: its prevalence and risk factor profile in the German general population. Dtsch Arztebl Int. 2012 Apr;109(16):293-9. doi: 10.3238/arztebl.2012.0293. Epub 2012 Apr 20. — View Citation
Stewart S, Hart CL, Hole DJ, McMurray JJ. A population-based study of the long-term risks associated with atrial fibrillation: 20-year follow-up of the Renfrew/Paisley study. Am J Med. 2002 Oct 1;113(5):359-64. — View Citation
Svennberg E, Engdahl J, Al-Khalili F, Friberg L, Frykman V, Rosenqvist M. Mass Screening for Untreated Atrial Fibrillation: The STROKESTOP Study. Circulation. 2015 Jun 23;131(25):2176-84. doi: 10.1161/CIRCULATIONAHA.114.014343. Epub 2015 Apr 24. — View Citation
Tieleman RG, Plantinga Y, Rinkes D, Bartels GL, Posma JL, Cator R, Hofman C, Houben RP. Validation and clinical use of a novel diagnostic device for screening of atrial fibrillation. Europace. 2014 Sep;16(9):1291-5. doi: 10.1093/europace/euu057. Epub 2014 May 13. — View Citation
Vaes B, Stalpaert S, Tavernier K, Thaels B, Lapeire D, Mullens W, Degryse J. The diagnostic accuracy of the MyDiagnostick to detect atrial fibrillation in primary care. BMC Fam Pract. 2014 Jun 9;15:113. doi: 10.1186/1471-2296-15-113. — View Citation
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991 Aug;22(8):983-8. — View Citation
* 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 |