Singapore Atrial Fibrillation Study

NCT02791022 | Unknown

• 1 other identifier: 2015/2309
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation is a common disease in the aging population that has severe implication if left untreated as it leads to embolic stroke and other embolic phenomenon. Embolic stroke in particular has severe implications to our community as the cost of care for such immobile patients can be extremely high. Atrial fibrillation typically begins as Paroxysmal atrial fibrillation (PAF), which makes early detection extremely difficult as the PAF may only occur transiently in the initial stages. Long term continuous ECG monitoring is currently required over weeks to detect early PAF. Current devices typically need to be implanted (loop recorders) to be sensitive enough to detect infrequent episodes of PAF. New generation ECG remote devices (non-invasive) are however now available that are wearable over long periods and can send data directly to a database for centralized collection and analysis of the data. The aim of this study will be to use such a device to evaluate the incidence of PAF in different population of patients, with each patient wearing and sending continuous ECG data for periods of a week or more to a central database, across several public hospitals in Singapore.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Paroxysmal Atrial Fibrillation

  1 year

Interventions

SPYDER ECG sensor DEVICE

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population is 2500 inpatients and outpatients recruited from 4 medical institutions over a period of 3 years Power Calculation: This is a pilot study exploring the utility of employing a wearable device to detect the prevalence of PAF in the study populations.

You may qualify if:

• Any male or female patient aged 21 years until 80 years old.
• Not diagnosed to have atrial fibrillation
• Patient must have sinus rhythm on 12 lead ECG prior to recruitment
• Patient must be living in Singapore.
• Ability to provide informed consent.
• Fulfill one or more of the risk factors stated below:
• i) Hypertension
• ii) Coronary arterial disease
• iii) Ischemic heart disease
• iv) Past history of congestive cardiac failure
• v) Cerebrovascular accident
• vi) Diabetes mellitus

You may not qualify if:

• Known atrial fibrillation
• Unable to use and manage a smartphone
• Skin allergy to adhesive tape or plaster
• Skin too hairy to apply device adhesive tape
• Unable to comply with investigator's instructions and study protocols.

Sponsors & Collaborators

• National Heart Centre Singapore: lead
• Changi General Hospital: collaborator
• Singapore General Hospital: collaborator
• National University Hospital, Singapore: collaborator

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Chi Keong Ching

  Singhealth Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanna Liaw

CONTACT

67042274; liaw.yin.siang@nhcs.com.sg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 6, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2019
• Last Updated: June 6, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)