Screening for Actionable Atrial Fibrillation During Preoperative Consultation With the MyDiagnostick

NCT02960334 | Completed

• 1 other identifier: 2016-076
• Study Type: observational
• Target: 505
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial Fibrillation (AF) It is the most common arrhythmia in the world. It carries great public health significance because of its prevalence, additional morbidity and mortality. It provides a 4-5 times higher risk of developing a ischemic stroke or transient ischemic attack. In term, this risk can be 70% reduced by taking oral anticoagulants. Actionable AF is the overarching term for silent AF (asymptomatic AF) and undertreated AF (known AF, but not sufficiently protected against ischemic stroke). It is recommended that over the age of 65, patients should be screened with pulse palpation or rhythm strip for the presence of AF. The MyDiagnostick is a single-lead I, compact hand-held device that analyses heart rhythm during one minute. During preoperative consultation, this device will be used to value the yield of screening for actionable AF.

Conditions

Atrial Fibrillation

Keywords

Screening; Silent Atrial Fibrillation; Undertreated Atrial Fibrillation; Actionable Atrial Fibrillation; MyDiagnostick; Opportunistic Screening; Preoperative Consultation; OAC; VKA; NOAC

Outcome Measures

Primary Outcomes (1)

• Presence of AF

  The MyDiagnostick shows regular or irregular RR-interval

  Single time point (when the patient visits the preoperative consultation hour)

Secondary Outcomes (1)

• Usage of OAC

  Single time point (when the patient visits the preoperative consultation hour)

Interventions

MyDiagnostick DEVICE

The MyDiagnostick is a compact hand-held device that registers and stores I-lead ECG strips. In one minute, t analyses the rhythm for the presence of AF. It distinguishes AF from normal cardiac rhythms by measuring RR-irregularity.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Every patient \> 64 years can participate in the trial. Patients who visit the preoperative consultation (e.g. before surgery) will be asked to hold the MyDiagnostick for one minute.

You may qualify if:

• \>64 years of age, visiting preoperative consultation

You may not qualify if:

• \<64 years of age

Sponsors & Collaborators

• Martini Hospital Groningen: lead

Study Sites (1)

Martini Ziekenhuis

Groningen, 9700 RM Groningen, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 9, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 31, 2017

Record last verified: 2017-08

Locations

NL (1)