Machine Learning Enabled Time Series Analysis in Medicine

Atrial Fibrillation Clinical Trial

— ME-TIME  

Official title:

Pattern Recognition in Heart Rate Variability Using Fitness Trackers in Cardiovascular Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05802563
• Other study ID #: metime
• Status: Enrolling by invitation
• Start date: May 24, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2023
• Source: HagaZiekenhuis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational cohort study is to investigate the potential of fitness trackers in combination with machine learning algorithms to identify cardiovascular disease specific patterns. Two hundred participants will be enrolled: 1. 50 with heart failure 2. 50 with atrial fibrillation 3. 100 (healthy) individuals without the former two conditions All participants are given a Fitbit device and monitored for three months. Researchers will compare differences in heart rate variability patterns between the groups and devise a machine learning algorithm to detect these patterns automatically.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• systolic heart failure (LVEF < 35%)
• Atrial fibrillation without heart failure
• Individuals without cardiovascular disease

Exclusion Criteria:

• > 85 years old
• Recent pulmonary venous antrum isolation procedure (<1 year)
• (end stage) kidney failure
• (end stage) liver failure
• Study participants with known systemic active inflammatory disease
• Study participants with impaired mental state
• Inability to use a fitness tracker or mobile phone
• Impaired cognition and inability to understand the study protocol

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure, Systolic

Intervention

Device:
• fitness tracker
Study subjects will wear a Fitbit fitness tracker

Locations

Country	Name	City	State
Netherlands	HagaZiekenhuis	Den Haag	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
HagaZiekenhuis	Delft University of Technology

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular disease detection with an AI algorithm	adequate sensitivity/specificity in an algorithm to detect atrial fibrillation and heart failure	Three months
Secondary	Detection of absence of cardiovascular disease		Three months