Pulse Signal Acquisition in Patients With Heart Failure (TCM PA)
Heart Failure (HF) is usually a chronic condition that gradually gets worse. The heart muscle becomes weaker and has trouble pumping blood to nourish the cells in human body. General symptoms are breathlessness, fatigue, ankle swelling. Accurate and timely diagnosis is crucial to ensure patients receive appropriate treatment. Patients often present to primary care clinicians, however diagnosis by primary care clinicians is inaccurate as symptoms and signs commonly overlap with other conditions. Only 26% of patients with a suspected HF have a confirmed diagnosis after formal investigation according to diagnostic criteria. There is a strong demand to develop an accurate, easy-to-use, costeffective device to detect HF in primary clinics or even by patients themselves before it is too late to modify the natural history of the disease.
TCM palpation provides a simple, cheap, and non-invasive approach for diagnosis and evaluation of the severity of HF, and does not involve use of expensive equipment. There are several specific pulse patterns associated with the clinical manifestation of HF. One of the project collaborators, a TCM physician with a PhD in Chinese Medicine, explained that patients with HF usually have alternating pulse strengths, strong pulse and subsequent weak pulses. The various degrees of severity can be readily manifested as Jiemai, Cumai, and Daimai on the pulse palpation. Based on the investigators' preliminary sensor test results, these pulse features can be easily detected using a micro tubular epidermal sensor, likewise developed by the investigators. Therefore, the investigators propose to use their micro tubular epidermal sensor to develop a TCM pulse analyser, which can be used by primary care clinicians and patient themselves to detect HF in a timely and accurate manner.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
-
Singapore, Singapore, 169609
- National Heart Centre Singapore
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 35 years and above.
- The recruited patients should have been diagnosed by NHCS's Doctor in charge with HF.
- Ability to provide informed consent.
Exclusion Criteria:
- Pregnant Women as their TCM pulse signal maybe different from normal (non-pregnant) time.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Intervention
Pulse signal measurement using measurement device
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TCM pulse signal data will be collected using project group developed pulse data collector, the collected TCM pulse signal is visible on the collector display screen.
Project staff will place the pulse collector cuff on the wrist of the participant.
During the process, the airbag in the cuff will be inflated with air several times to press the pressure sensor against participants' wrist and deflated several times to release the pressure.
Under different airbag pressure, the TCM pulse signal from different depths (Fu, Zhong, and Chen) against the wrist will be collected.
During the test, the project staff will move the cuff along the wrist to collect the TCM pulse signal from different wrist positions (Cun, Guan, and Chi) according to TCM theory.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
AI-developed Heart Failure detection algorithm
Time Frame: On the day of enrollment
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To develop pulse pattern feature extraction, selection, and classification models using AI approaches with a premier focus on HF detection, based on TCM theory.
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On the day of enrollment
|
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Pulse data acquisition from HF patients and non-HF people
Time Frame: On the day of enrollment
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To collect pulse data from HF patients and non-HF people to train and test the machine learning models developed based on AI methods.
|
On the day of enrollment
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2022-2338
- MOE-MOE2020-TIF-0005 (Other Grant/Funding Number: MOE TRANSLATIONAL R&D AND INNOVATION FUND (TIF))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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