Carotid Artery DiseasesINDICESNCT03217214
Investigation of Contact Based Method for Diagnosis of Cardiovascular Disease
An observational study of Carotid Artery Diseases, run by National Heart Centre Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Carotid Artery Diseases
- What is being tested?
- Thermography
- How many people
- 67 participants
- Where
- 1 siteSingapore
- Study dates
- 19 Sep 2017to 30 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinical indication for Duplex Carotid Ultrasound for arterial stenosis detection
Who may be able to join
- Aged between 35 - 70
- Planned for Duplex carotid artery duplex scan
- Ability to provide informed consent
Who cannot join
- Known significant stenosis / disease in subclavian artery
- Known multiple stenoses or occlusion in cerebral (carotid / vertebral / intracranial ) circulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of a Non-invasive/ Minimally Contact Based Method for Diagnosis of Cardiovascular Disease: Blockage(Stenosis) and Blood Flow
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.
Read the detailed description
HYPOTHESIS AND OBJECTIVES 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 Infrared 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). In any scenario, 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.
- In the proposed hypothesis, a momentarily higher heat transfer window will be created using localized cooling of a small section of the skin over the superficial blood vessel (minimally contact) and hence, the warming process will be tracked using a non-contact and non-invasive Infrared temperature sensor. With the formation of plaques in the arteries at main aorta, carotid bifurcation or anywhere in the vessel, the flow turns into chaotic turbulent kind or in the case of blockage a very low or no blood flow, which impacts the heat transfer from the blood flow and can be easily detected from the heat transfer over the skin during that momentarily higher heaty transfer window.
- In order to apply this approach to Cardiovascular diseases diagnosis one of the probable method could be scanning temperature change at two locations of the body:
- On both carotid artery on left and right of the neck.
- On both superficial temporal artery on the left and right of the forehead.
- It is expected that skin thermal variation at the forearm will always be in a relation to the blood flow in carotid artery for a healthy person that could be used as a signature marker for an individual to make comparison. Therefore, temperature mapping of the left forearm (upper limb).
This study involves 3 different techniques to be tested on 100 human subjects. Existing procedure to be used will be readily available Duplex Ultrasound that is considered as more reliable in clinical practice. Since the new technology involves temperature mapping, existing potential thermography technique (Passive Thermography) will be used to setup the baseline data. Other than this, 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. Accordingly, the whole study is divided into two parts: phase-1 and phase-2 as shown in Figure 2. By the time, the Active Thermography technique will be developed; data collection with the techniques mentioned in phase-1 will be completed.
Phase-1
Existing Technology: Duplex Ultrasound exam will be done on all the subjects to divide them into two groups as healthy and diseased.
Passive Thermography (PT): The study procedures involve taking 2 thermoscans of the following parts:
- Both carotid artery on left and right of the neck.
- Both superficial temporal artery on the left and right of the forehead.
- Left forearm (upper limb).
No relaxation time will be given between any of the two tests. Each thermoscanning of individual regions of measurement (ROM) will take around 60 seconds. The complete procedure will take around 10-15 minutes of time.
Phase-2
Existing Technology: Duplex Ultrasound exam will be done on all the subjects to divide them into two groups as healthy and diseased.
Active Thermography (AT): For this case, temperature mapping over both carotid arteries will be done with the application of maximum cooling (within comfort limit) for 45-60 seconds either in pulsed or lock-in manner. While pulsed mode is the continuous application of cooling, lock-in cooling will be intermittent. The frequency of application of cooling under lock-in cooling method is yet to be decided. However, for both the methods, maximum cooling time will remain fixed as 45-60 seconds. The final cooling method to be used is yet to be decided. Cooling will be done either through a cooling pad or using a cold air blower. The temperature of the cooling fluid in the cooling pad and air for the blower will be maintained in the range of 0oC to 5oC (provisionally), respectively. Due to application of cooling, the localized skin tissue will cool down and start rewarming to attain equilibrium temperature with the ambient as earlier (before application of cooling). A continuous thermoscanning will be done from the instance of application of cooling to the reaching of a fixed temperature (to be decided) during the rewarming. However, the maximum acquisition time after the removal of cooling will be kept fixed to 180 seconds. This procedure will be done 2 times for each subject on both carotid arteries. The relaxation time between every procedure will be 10 minutes. A warming pad or hot air blower will be used after every run of the test so as to quickly bring the skin temperature to normal. Temperature of the hot fluid in the warming pad or warm air through blower will be kept slightly higher than room temperature but less than body core temperature (provisionally in the range of 25oC to 35 oC). The total time for the complete procedure would be around 60 min.
Taking all the standard clinical procedure care, there is no risk of any adverse condition as the whole process of data collection is completely non-invasive and minimally contact (only for phase-2 study).
- Conditions
- Carotid Artery Diseases
- Being tested
- Thermography
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermographyDiagnostic test
Passive thermography for Phase I subjects and Active Thermography for Phase II subjects
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Thermography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin thermal variation
Flow of blood from thermal performance of the skin can be tracked
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start19 Sep 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University
- Responsible party
- Sponsor
- Investigators
- A/Prof Lim Soo Teik, MBBS, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217214
- Sponsor's protocol ID
- 2017/2119
- Acronym
- INDICES
- Status last verified
- Oct 2018
- First submitted
- 11 Jul 2017
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of a Non-invasive/ Minimally Contact Based Method for Diagnosis of Cardiovascular Disease: Blockage(Stenosis) and Blood Flow
- ClinicalTrials.gov ID
- NCT03217214
- Acronym / sponsor ID
- INDICES / 2017/2119
- Conditions
- Carotid Artery Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Nanyang Technological University
- Study start
- 19 Sep 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
HYPOTHESIS AND OBJECTIVES 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 Infrared 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). In any scenario, 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.
- In the proposed hypothesis, a momentarily higher heat transfer window will be created using localized cooling of a small section of the skin over the superficial blood vessel (minimally contact) and hence, the warming process will be tracked using a non-contact and non-invasive Infrared temperature sensor. With the formation of plaques in the arteries at main aorta, carotid bifurcation or anywhere in the vessel, the flow turns into chaotic turbulent kind or in the case of blockage a very low or no blood flow, which impacts the heat transfer from the blood flow and can be easily detected from the heat transfer over the skin during that momentarily higher heaty transfer window.
- In order to apply this approach to Cardiovascular diseases diagnosis one of the probable method could be scanning temperature change at two locations of the body:
- On both carotid artery on left and right of the neck.
- On both superficial temporal artery on the left and right of the forehead.
- It is expected that skin thermal variation at the forearm will always be in a relation to the blood flow in carotid artery for a healthy person that could be used as a signature marker for an individual to make comparison. Therefore, temperature mapping of the left forearm (upper limb).
This study involves 3 different techniques to be tested on 100 human subjects. Existing procedure to be used will be readily available Duplex Ultrasound that is considered as more reliable in clinical practice. Since the new technology involves temperature mapping, existing potential thermography technique (Passive Thermography) will be used to setup the baseline data. Other than this, 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. Accordingly, the whole study is divided into two parts: phase-1 and phase-2 as shown in Figure 2. By the time, the Active Thermography technique will be developed; data collection with the techniques mentioned in phase-1 will be completed.
Phase-1
Existing Technology: Duplex Ultrasound exam will be done on all the subjects to divide them into two groups as healthy and diseased.
Passive Thermography (PT): The study procedures involve taking 2 thermoscans of the following parts:
- Both carotid artery on left and right of the neck.
- Both superficial temporal artery on the left and right of the forehead.
- Left forearm (upper limb).
No relaxation time will be given between any of the two tests. Each thermoscanning of individual regions of measurement (ROM) will take around 60 seconds. The complete procedure will take around 10-15 minutes of time.
Phase-2
Existing Technology: Duplex Ultrasound exam will be done on all the subjects to divide them into two groups as healthy and diseased.
Active Thermography (AT): For this case, temperature mapping over both carotid arteries will be done with the application of maximum cooling (within comfort limit) for 45-60 seconds either in pulsed or lock-in manner. While pulsed mode is the continuous application of cooling, lock-in cooling will be intermittent. The frequency of application of cooling under lock-in cooling method is yet to be decided. However, for both the methods, maximum cooling time will remain fixed as 45-60 seconds. The final cooling method to be used is yet to be decided. Cooling will be done either through a cooling pad or using a cold air blower. The temperature of the cooling fluid in the cooling pad and air for the blower will be maintained in the range of 0oC to 5oC (provisionally), respectively. Due to application of cooling, the localized skin tissue will cool down and start rewarming to attain equilibrium temperature with the ambient as earlier (before application of cooling). A continuous thermoscanning will be done from the instance of application of cooling to the reaching of a fixed temperature (to be decided) during the rewarming. However, the maximum acquisition time after the removal of cooling will be kept fixed to 180 seconds. This procedure will be done 2 times for each subject on both carotid arteries. The relaxation time between every procedure will be 10 minutes. A warming pad or hot air blower will be used after every run of the test so as to quickly bring the skin temperature to normal. Temperature of the hot fluid in the warming pad or warm air through blower will be kept slightly higher than room temperature but less than body core temperature (provisionally in the range of 25oC to 35 oC). The total time for the complete procedure would be around 60 min.
Taking all the standard clinical procedure care, there is no risk of any adverse condition as the whole process of data collection is completely non-invasive and minimally contact (only for phase-2 study).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EP-PT | – | Diagnostic Test: ThermographyExisting 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. |
| EP-ATLIC/ATPC | – | Diagnostic Test: ThermographyExisting 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. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinical indication for Duplex Carotid Ultrasound for arterial stenosis detection
Key inclusion criteria (3 listed)
- Aged between 35 - 70
- Planned for Duplex carotid artery duplex scan
- Ability to provide informed consent
Key exclusion criteria (2 listed)
- Known significant stenosis / disease in subclavian artery
- Known multiple stenoses or occlusion in cerebral (carotid / vertebral / intracranial ) circulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermographyPassive thermography for Phase I subjects and Active Thermography for Phase II subjects | Diagnostic test | EP-ATLIC/ATPC, EP-PT |
Primary outcome
Skin thermal variation
Time frame: 2 years
Flow of blood from thermal performance of the skin can be tracked
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Carotid Artery Diseases
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruiting
UltraTrac for Cardiac Output Monitoring in Congenital Heart Disease
Congenital Heart Disease, Cardiac Output
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A/Prof Lim Soo Teik, MBBS principal investigator
National Heart Centre Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Diseases, run by National Heart Centre Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin thermal variation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.