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Singapore Atrial Fibrillation Study (SAFS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02791022
Recruitment Status : Unknown
Verified May 2016 by National Heart Centre Singapore.
Recruitment status was:  Recruiting
First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Sponsor:
Collaborators:
Changi General Hospital
Singapore General Hospital
National University Hospital, Singapore
Information provided by (Responsible Party):
National Heart Centre Singapore

Tracking Information
First Submitted Date May 30, 2016
First Posted Date June 6, 2016
Last Update Posted Date June 6, 2016
Study Start Date March 2016
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 2, 2016)
Paroxysmal Atrial Fibrillation [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Singapore Atrial Fibrillation Study
Official Title A Multi-centre Population-based Study on the Incidence of Paroxysmal Atrial Fibrillation in Inpatient and Outpatient Cohorts in Singapore
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.
Detailed 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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition Atrial Fibrillation
Intervention Device: SPYDER ECG sensor
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 2, 2016)
2500
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Singapore
Removed Location Countries  
 
Administrative Information
NCT Number NCT02791022
Other Study ID Numbers 2015/2309
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party National Heart Centre Singapore
Study Sponsor National Heart Centre Singapore
Collaborators
  • Changi General Hospital
  • Singapore General Hospital
  • National University Hospital, Singapore
Investigators
Principal Investigator: Chi Keong Ching Singhealth Foundation
PRS Account National Heart Centre Singapore
Verification Date May 2016