Investigation of Contact Based Method for Diagnosis of Cardiovascular Disease

NCT03217214 | Completed

• 1 other identifier: 2017/2119
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

In the proposed method of sensing the vital health sign related to cardiovascular diseases, thermal heat transfer performance of the skin will be evaluated using a non-contact based Infra-Red temperature sensor. The temperature of the skin is significantly dependent upon the heat source as blood vessels (veins and capillaries) in the vicinity of the skin. However, there are several locations in the human body, where arteries are also at a relatively less depth from the outer skin surface (radial or ulnar arteries at the wrist and carotid artery in the neck). If it is possible to track the flow of blood from the thermal performance of the skin, then it could be useful in predicting various states of the human health related to cardiovascular activities. Subjects will undergo Existing Procedure EP- Passive Thermography PT for Phase I and Existing Procedure EP- Active Thermography ATLIC/ATPC for Phase II, with Duplex Ultrasound being the existing procedure that is considered as more reliable in clinical practice. Existing Passive Thermography will be used to setup the baseline data for Phase I. The currently under-development temperature mapping method (Active Thermography) that involves application of cooling (either pulsed or lock-in cooling) over the skin will be utilized for Phase II.

Conditions

Carotid Artery Diseases

Outcome Measures

Primary Outcomes (1)

• Skin thermal variation

  Flow of blood from thermal performance of the skin can be tracked

  2 years

Study Arms (2)

EP-PT

Existing Procedure EP- Passive Thermography PT (40 patients) Passive Thermography (PT): 2 thermoscans of the following parts: 1. Both carotid artery on left and right of the neck. 2. Both superficial temporal artery on the left and right of forehead. 3. Left forearm. No relaxation time will be given between the two tests. Each thermoscanning of region will take 60 seconds. The complete procedure will take 10-15 minutes of time.

Diagnostic Test: Thermography

EP-ATLIC/ATPC

Existing Procedure EP- Active Thermography ATLIC/ATPC (60 patients) Active Thermography (AT): Temperature mapping over both carotid arteries will be done with the application of maximum cooling for 45-60 seconds in pulsed or lock-in manner. Pulsed mode is continuous, lock-in cooling will be intermittent. Maximum cooling time is 45-60 seconds, using a cooling pad/ cold air blower. Continuous thermoscanning will be done from the instance of application of cooling to reaching of a fixed temperature during rewarming. Procedure will be done 2 times per subject on both carotid arteries. Relaxation time between procedures is 10 minutes. A warming pad/ hot air blower will be used after the test to bring the skin temperature to normal. The complete procedure will take 60 min.

Diagnostic Test: Thermography

Interventions

Thermography DIAGNOSTIC_TEST

Passive thermography for Phase I subjects and Active Thermography for Phase II subjects

EP-ATLIC/ATPC; EP-PT

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with clinical indication for Duplex Carotid Ultrasound for arterial stenosis detection

You may qualify if:

• Aged between 35 - 70
• Planned for Duplex carotid artery duplex scan
• Ability to provide informed consent

You may not qualify if:

• Known significant stenosis / disease in subclavian artery
• Known multiple stenoses or occlusion in cerebral (carotid / vertebral / intracranial ) circulation

Sponsors & Collaborators

• National Heart Centre Singapore: lead
• Nanyang Technological University: collaborator

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

Thermography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Thermometry; Investigative Techniques

Study Officials

• A/Prof Lim Soo Teik, MBBS

  National Heart Centre Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 14, 2017
• Study Start: September 19, 2017
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: April 19, 2021

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)