- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02791022
Singapore Atrial Fibrillation Study (SAFS)
A Multi-centre Population-based Study on the Incidence of Paroxysmal Atrial Fibrillation in Inpatient and Outpatient Cohorts in Singapore
Study Overview
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Hanna Liaw
- Phone Number: 67042274
- Email: liaw.yin.siang@nhcs.com.sg
Study Locations
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Singapore, Singapore, 169609
- Recruiting
- National Heart Centre Singapore
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Contact:
- Hanna Liaw
- Phone Number: 67042274
- Email: liaw.yin.siang@nhcs.com.sg
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Principal Investigator:
- Chi Keong Ching
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Paroxysmal Atrial Fibrillation
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chi Keong Ching, Singhealth Foundation
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015/2309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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