Singapore Atrial Fibrillation Study

Atrial Fibrillation Clinical Trial

— SAFS  

Official title:

A Multi-centre Population-based Study on the Incidence of Paroxysmal Atrial Fibrillation in Inpatient and Outpatient Cohorts in Singapore

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02791022
• Other study ID #: 2015/2309
• Status: Recruiting
• Phase: N/A
• First received: May 30, 2016
• Last updated: June 2, 2016
• Start date: March 2016

Study information

• Verified date: May 2016
• Source: National Heart Centre Singapore
• Contact: Hanna Liaw
• Phone: 67042274
• Email: liaw.yin.siang[@]nhcs.com.sg
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

The implications of PAF detection in an individual are huge to the individual and the community as it increases the risk of embolic stroke and other embolic phenomenon. Once detected, intervention can be taken to lower such an individual's clinical risk and decrease the clinical burden to the community. The lack of suitable tools and large population cohorts has led to a likely underestimation of PAF in various patient populations. This study will specifically address and characterize the different incidence on PAF in various patient populations and hence help to target at risk groups for earlier screening and intervention.

Patients with HF are more likely than the general population to develop AF. Conversely AF is also a strong independent risk factor for subsequent development of HF.

In Heart Failure (HF) patients, later development of AF was associated with increased mortality. Preexisting HF adversely affected survival in individuals with AF. Both HF with reduced ejection fraction (HFrEF) and Heart Failure with a Preserved Ejection Fraction (HFpEF) patients are at greater risk for AF. There is a direct relationship between functional state (as shown by the NYHA class) and prevalence of AF in patients with HF progressing from 4% in those who are NYHA class I to 40% in those who are NYHA class IV.

Acute HF decompensation in patients with prior HF is due to AF as a precipitant in 5.4% of cases in a single center study.

Knowing the true prevalence of AF in HF will allow us to plan for strategies to further reduce the clinical burden of HF.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Any male or female patient aged 21 years until 80 years old.

2. Not diagnosed to have atrial fibrillation

3. Patient must have sinus rhythm on 12 lead ECG prior to recruitment

4. Patient must be living in Singapore.

5. Ability to provide informed consent.

6. . 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

Exclusion Criteria:

1. Known atrial fibrillation

2. Unable to use and manage a smartphone

3. Skin allergy to adhesive tape or plaster

4. Skin too hairy to apply device adhesive tape

5. Unable to comply with investigator's instructions and study protocols.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• SPYDER ECG sensor

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore

Sponsors (4)

Lead Sponsor	Collaborator
National Heart Centre Singapore	Changi General Hospital, National University Hospital, Singapore, Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paroxysmal Atrial Fibrillation		1 year	No