Silent Atrial Fibrillation - Screening of High-risk Groups for Atrial Fibrillation (The Silence Study)

NCT02893215 | Unknown DMC

• 1 other identifier: H-16015331
• Study Type: observational
• Target: 1,622
• Locations: 3 countries
• Sites: 9

Brief Summary

The primary aim of the present study is to screen high-risk type 2 diabetes patients and heart failure patients without any history of atrial fibrillation (AF), ongoing oral anticoagulation (OAC) treatment, implanted device or recent stroke/Transient Ischemic Attack (TIA), for silent AF. Moreover, we aim to establish the prevalence of two or more risk factors for stroke in patients with heart failure and diabetes mellitus type 2 (DM2) with the aim of assessing the feasibility for this group to undergo AF screening. Overall, the aim of the study is to prevent stroke in high-risk patients groups through identification of silent (asymptomatic) atrial fibrillation.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Number of participants with silent atrial fibrillation as assessed by handheld ECG measurements in high-risk heart failure patients.

  14 days

• Number of participants with silent atrial fibrillation as assessed by handheld ECG measurements in high-risk type 2 diabetes patients.

  14 days

Secondary Outcomes (4)

• Number of participants with supraventricular ectopic activity.

  14 days

• Number of participants with micro-atrial fibrillation.

  14 days

• Number of participants with high risk of stroke in a heart failure population.

  2 years

• Number of participants with high risk of stroke in a type 2 diabetes population.

  2 years

Study Arms (2)

Heart failure

Screening for silent AF with Zenicor thumb-ECG: Patients older than 65 years, diagnosed with heart failure, without any history of atrial fibrillation, ongoing OAC treatment, implanted device or recent stroke/TIA.

Other: Screening for silent AF with Zenicor thumb-ECG

Diabetes mellitus II

Screening for silent AF with Zenicor thumb-ECG: Patients older than 65 years, diagnosed with diabetes mellitus II, without any history of atrial fibrillation, ongoing OAC treatment, implanted device or recent stroke/TIA.

Other: Screening for silent AF with Zenicor thumb-ECG

Interventions

Screening for silent AF with Zenicor thumb-ECG OTHER

Each patient has a device for 14 days, which monitorizes their heart rhythm. They send the ecg four times daily.

Also known as: Zenicor Medical Systems

Diabetes mellitus II; Heart failure

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with congestive heart failure and without any history of atrial fibrillation, ongoing OAC treatment, implanted device or recent stroke/TIA Patients with DM-II and without any history of atrial fibrillation, ongoing OAC treatment, implanted device or recent stroke/TIA

You may qualify if:

• Systolic Congestive Heart Failure diagnosed by echocardiography showing a left ventricular ejection fraction (LVEF) ≤ 40%.
• Diagnosed Diabetes Mellitus type II.
• Age 65 years or older
• CHADS-Vasc (Risk score) 2 or higher

You may not qualify if:

• Previous history of AF
• Ongoing OAC treatment
• Implanted device
• Recent stroke/TIA

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (9)

Department of Cardiology, Krankenhaus der Elisabethinen

Linz, Austria

RECRUITING

Kepler Universitätsklinikum GmbH

Linz, Austria

RECRUITING

Krankenhaus der Barmherzigen Brüder Linz

Linz, Austria

RECRUITING

Hvidovre University Hospital, Department of cardiology

Hvidovre, 2650, Denmark

RECRUITING

Bjurholms Hälsocentral

Bjurholm, Sweden

ACTIVE NOT RECRUITING

Grytnäs Hälsocentral

Kalix, Sweden

ACTIVE NOT RECRUITING

The Karolinske Institute, Department of Cardiology, Danderyd Hospital

Stockholm, Sweden

ACTIVE NOT RECRUITING

Ålidhems Hälsocentral

Umeå, Sweden

ACTIVE NOT RECRUITING

Vindelns Hälsocentral

Vindeln, Sweden

ACTIVE NOT RECRUITING

Related Publications (22)

• Kannel WB, Benjamin EJ. Status of the epidemiology of atrial fibrillation. Med Clin North Am. 2008 Jan;92(1):17-40, ix. doi: 10.1016/j.mcna.2007.09.002.

  PMID: 18060995 BACKGROUND

• Qvist JF, Sorensen PH, Dixen U. Hospitalisation patterns change over time in patients with atrial fibrillation. Dan Med J. 2014 Jan;61(1):A4765.

  PMID: 24393590 BACKGROUND

• Friberg L, Bergfeldt L. Atrial fibrillation prevalence revisited. J Intern Med. 2013 Nov;274(5):461-8. doi: 10.1111/joim.12114. Epub 2013 Aug 7.

  PMID: 23879838 BACKGROUND

• 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.

  PMID: 25910800 BACKGROUND

• Flegel KM, Shipley MJ, Rose G. Risk of stroke in non-rheumatic atrial fibrillation. Lancet. 1987 Mar 7;1(8532):526-9. doi: 10.1016/s0140-6736(87)90174-7.

  PMID: 2881082 BACKGROUND

• Wolf PA, Dawber TR, Thomas HE Jr, Kannel WB. Epidemiologic assessment of chronic atrial fibrillation and risk of stroke: the Framingham study. Neurology. 1978 Oct;28(10):973-7. doi: 10.1212/wnl.28.10.973.

  PMID: 570666 BACKGROUND

• Friberg L, Hammar N, Rosenqvist M. Stroke in paroxysmal atrial fibrillation: report from the Stockholm Cohort of Atrial Fibrillation. Eur Heart J. 2010 Apr;31(8):967-75. doi: 10.1093/eurheartj/ehn599. Epub 2009 Jan 27.

  PMID: 19176537 BACKGROUND

• Hart RG, Pearce LA, Rothbart RM, McAnulty JH, Asinger RW, Halperin JL. Stroke with intermittent atrial fibrillation: incidence and predictors during aspirin therapy. Stroke Prevention in Atrial Fibrillation Investigators. J Am Coll Cardiol. 2000 Jan;35(1):183-7. doi: 10.1016/s0735-1097(99)00489-1.

  PMID: 10636278 BACKGROUND

• Savelieva I, Camm AJ. Clinical relevance of silent atrial fibrillation: prevalence, prognosis, quality of life, and management. J Interv Card Electrophysiol. 2000 Jun;4(2):369-82. doi: 10.1023/a:1009823001707.

  PMID: 10936003 BACKGROUND

• Rizos T, Wagner A, Jenetzky E, Ringleb PA, Becker R, Hacke W, Veltkamp R. Paroxysmal atrial fibrillation is more prevalent than persistent atrial fibrillation in acute stroke and transient ischemic attack patients. Cerebrovasc Dis. 2011;32(3):276-82. doi: 10.1159/000330348. Epub 2011 Aug 31.

  PMID: 21893980 BACKGROUND

• Healey JS, Connolly SJ, Gold MR, Israel CW, Van Gelder IC, Capucci A, Lau CP, Fain E, Yang S, Bailleul C, Morillo CA, Carlson M, Themeles E, Kaufman ES, Hohnloser SH; ASSERT Investigators. Subclinical atrial fibrillation and the risk of stroke. N Engl J Med. 2012 Jan 12;366(2):120-9. doi: 10.1056/NEJMoa1105575.

  PMID: 22236222 BACKGROUND

• Glotzer TV, Hellkamp AS, Zimmerman J, Sweeney MO, Yee R, Marinchak R, Cook J, Paraschos A, Love J, Radoslovich G, Lee KL, Lamas GA; MOST Investigators. Atrial high rate episodes detected by pacemaker diagnostics predict death and stroke: report of the Atrial Diagnostics Ancillary Study of the MOde Selection Trial (MOST). Circulation. 2003 Apr 1;107(12):1614-9. doi: 10.1161/01.CIR.0000057981.70380.45. Epub 2003 Mar 24.

  PMID: 12668495 BACKGROUND

• Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA. 2001 Jun 13;285(22):2864-70. doi: 10.1001/jama.285.22.2864.

  PMID: 11401607 BACKGROUND

• 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.

  PMID: 19762550 BACKGROUND

• Indredavik B, Rohweder G, Lydersen S. Frequency and effect of optimal anticoagulation before onset of ischaemic stroke in patients with known atrial fibrillation. J Intern Med. 2005 Aug;258(2):133-44. doi: 10.1111/j.1365-2796.2005.01512.x.

  PMID: 16018790 BACKGROUND

• Saxena R, Lewis S, Berge E, Sandercock PA, Koudstaal PJ. Risk of early death and recurrent stroke and effect of heparin in 3169 patients with acute ischemic stroke and atrial fibrillation in the International Stroke Trial. Stroke. 2001 Oct;32(10):2333-7. doi: 10.1161/hs1001.097093.

  PMID: 11588322 BACKGROUND

• Marini C, De Santis F, Sacco S, Russo T, Olivieri L, Totaro R, Carolei A. Contribution of atrial fibrillation to incidence and outcome of ischemic stroke: results from a population-based study. Stroke. 2005 Jun;36(6):1115-9. doi: 10.1161/01.STR.0000166053.83476.4a. Epub 2005 May 5.

  PMID: 15879330 BACKGROUND

• Marfella R, Sasso FC, Siniscalchi M, Cirillo M, Paolisso P, Sardu C, Barbieri M, Rizzo MR, Mauro C, Paolisso G. Brief episodes of silent atrial fibrillation predict clinical vascular brain disease in type 2 diabetic patients. J Am Coll Cardiol. 2013 Aug 6;62(6):525-30. doi: 10.1016/j.jacc.2013.02.091. Epub 2013 May 15.

  PMID: 23684685 BACKGROUND

• Hendrikx T, Hornsten R, Rosenqvist M, Sandstrom H. Screening for atrial fibrillation with baseline and intermittent ECG recording in an out-of-hospital population. BMC Cardiovasc Disord. 2013 Jun 10;13:41. doi: 10.1186/1471-2261-13-41.

  PMID: 23758799 BACKGROUND

• Hendrikx T, Rosenqvist M, Sandstrom H, Persson M, Hornsten R. [Identification of paroxysmal, transient arrhythmias: Intermittent registration more efficient than the 24-hour Holter monitoring]. Lakartidningen. 2015 Jan 6;112:C6SE. Swedish.

  PMID: 25584602 BACKGROUND

• Rizzo MR, Sasso FC, Marfella R, Siniscalchi M, Paolisso P, Carbonara O, Capoluongo MC, Lascar N, Pace C, Sardu C, Passavanti B, Barbieri M, Mauro C, Paolisso G. Autonomic dysfunction is associated with brief episodes of atrial fibrillation in type 2 diabetes. J Diabetes Complications. 2015 Jan-Feb;29(1):88-92. doi: 10.1016/j.jdiacomp.2014.09.002. Epub 2014 Sep 16.

  PMID: 25266244 BACKGROUND

• Stamboul K, Zeller M, Fauchier L, Gudjoncik A, Buffet P, Garnier F, Guenancia C, Lorgis L, Beer JC, Touzery C, Cottin Y. Incidence and prognostic significance of silent atrial fibrillation in acute myocardial infarction. Int J Cardiol. 2014 Jul 1;174(3):611-7. doi: 10.1016/j.ijcard.2014.04.158. Epub 2014 Apr 22.

  PMID: 24801093 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Ulrik Dixen, MD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrik Dixen, MD

CONTACT

+4538621050; ulrik.dixen@regionh.dk

Valborg Heinesen, MD

CONTACT

valborgheinesen@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: September 8, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2020
• Last Updated: November 3, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); SE (5); AU (3)