AtherosclerosisDOTNCT03411213
Quantitative Assessment and Characterization of Microvascular Function Using Diffuse Optical Tomography
A study testing diffuse optical tomography in people with Atherosclerosis and Diabetes, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Atherosclerosis is accompanied by microvascular dysfunction (an impairment of blood vessels to dilate or constrict in response to demand). The ability to reliably measure microvascular dysfunction would help identify patients at risk of myocardial infarction and test new treatments. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Diabetes, Coronary Artery Disease
- What is being tested?
- diffuse optical tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2016to 26 Mar 2020
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-80 of either sex
- Ability to read and speak English to a level allowing understanding of the patient information and to give consent to participate
- Diagnosed as type 2 diabetic for at least 12 months
- No painful arms or health problems preventing blood pressure cuff inflation
- No lymphoedema of the arm
- Not diabetic or known to have suffered a myocardial infarction in the past
Who cannot join
- Any patients that do not meet the above criteria will be excluded
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northern General Hospital
Sheffield, South Yorkshire, S5 7AU
About this study
Official title: Quantitative Assessment and Characterization of Microvascular Function Using Diffuse Optical Tomography Version
Atherosclerosis is accompanied by microvascular dysfunction (an impairment of blood vessels to dilate or constrict in response to demand). The ability to reliably measure microvascular dysfunction would help identify patients at risk of myocardial infarction and test new treatments. All existing measures of microvascular dysfunction suffer significant limitations.
Near Infrared Spectroscopy (NIRS) is an imaging method that uses an infrared light-source and detector (called optodes) to painlessly shines light into tissue and collect reflected light at different wavelengths. This data allows quantification of the amount of haemoglobin (blood) in the tissue and whether it is oxygenated or de-oxygenated.
Read more
Diffuse optical tomography (DOT) is a powerful analysis technique for data collected from multiple NIRH optodes. Unlike most NIRS studies that use a single pair of optodes and collects a single datapoint for each wavelength over time, DOT allows three-dimensional spatial reconstruction of haemodynamic and anatomic changes in a large region of tissue over time.
In preliminary work DOT had the potential to measure forearm reactive hyperaemia, a key indicator of microvascular function. Team will test whether DOT can detect differences between patients and healthy volunteers.
In this work, 30 patients will be recruited with type 2 diabetes, 30 patients who have had a previous myocardial infarction and 30 healthy volunteers. The Investigator will also recruit 50 patients who are on waiting lists for coronary angiography.
The DOT will be used to measure participants' microvascular function after brachial artery occlusion by a blood pressure cuff. The Investigator will then examine whether DOT can detect differences between healthy volunteers, diabetics, and patients with a previous heart attack, and whether DOT is able to predict existence of coronary artery disease on angiography. If successful, DOT can be developed for assessment of microvascular function to the point where it could be applied to clinical studies.
Read the detailed description
Previous pilot studies have shown ability to collect promising data safely. In the following studies, the same study as in the pilot will be performed to apply the array of optodes to the surface of the arm. These emit light painlessly into the tissue and collect scattered light from the tissue. Inflation of a blood pressure cuff around the arm for 5 minutes, then deflate the cuff to allow blood flow back into the tissue. From the data gathered before, during and after the cuff is inflated, 3D reconstructions can be performed of HbO, HbR, and HbT changes in the forearm during and after arterial occlusion.
Study 1) Can DOT detect differences in vascular function between healthy volunteers and patients with proven heart disease or diabetes
This study will measure vascular function in patients with known heart disease (previous myocardial infarction) or diabetes and compare this to matched healthy volunteers. This will establish whether DOT can detect differences in vascular response between these groups. If so, then the method has the potential to be useful diagnostically or prognostically.
Potential participants will be approached by poster, or face to face in STH clinics and provided with the information sheet which participants will be asked to read at home. Participants will be given the opportunity to ask questions by email or telephone at any time afterwards. Participants will be asked to contact us if they are willing to participate.
Participants will be booked with an appointment to attend the Clinical Research Facility at Sheffield Teaching Hospitals (at least 24hrs after receiving the information sheet and having the chance to ask questions) for a visit of 30-45 minutes. Visits will be arranged in advance at a convenient time.
When participants attend, after agreeing to take part and signing a consent form, participants will take a seat in a private room. Participants will need to wear short sleeves, or roll their sleeves up. If necessary, the investigator can provide a gown to wear if the sleeves are too tight. The investigator will then do the following;
- Record some details about medical history, height/weight, whether they take medications, date of birth, whether male or female.
- Measure the blood pressure by briefly inflating a cuff around the upper arm.
- Place an array of fibre optics on the surface of the forearm. Some jelly will be placed on the skin first, and the array will be held in place by a strap or tape. This is not painful.
- After around 10 minutes of sitting quietly, the investigator will inflate a blood pressure cuff around the arm that the array is placed on. This will temporarily prevent blood entering or leaving the arm. This will feel tight and the arm may go numb. The investigator will keep the cuff inflated for five minutes, but the participant can ask for the cuff to be deflated at any time.
- The investigator will then deflate the cuff, allowing blood back into the arm. After around 10 more minutes, the investigator will remove the cuff and array and the participant will be free to leave.
After the first assessment, the investigator will ask participants if they would be willing to attend for a second assessment where we would repeat the above measurements. This is to test how reproducible the measurements are in the same individual.
Study 2) Can DOT predict presence or severity of coronary artery disease on angiography?
This study will measure vascular function in patients awaiting diagnostic coronary angiography (either invasive or by CT), in whom it is not known whether or not coronary artery disease is present. Once the angiographic results are available the investigator will correlate vascular function measured by DOT with presence and severity of coronary artery disease to examine whether or not DOT identified
Potential participants will be approached by poster, or face to face in STH clinics and provided with the information sheet which participants will be asked to read. Participants will be given the opportunity to ask questions by email or telephone at any time afterwards. Participants will be asked to contact us if they are willing to participate.
Participants will be booked with an appointment to attend the Clinical Research Facility at Sheffield Teaching Hospitals (at least 24hrs after receiving the information sheet and having the chance to ask questions) for a visit of approximately 45 minutes. Visits will be arranged in advance at a convenient time.
When participants attend, after agreeing to take part and signing a consent form, particpants will take a seat in a private room. Participants will need to wear short sleeves, or roll their sleeves up. If necessary, the investigator can provide a gown to wear if the sleeves are too tight. the investigator will then do the following;
- Record some details about medical history, whether they take medications, date of birth, whether male or female.
- Measure the blood pressure by briefly inflating a cuff around the upper arm.
- Place an array of fibre optics on the surface of the forearm. Some jelly will be placed on the skin first, and the array will be held in place by a strap or tape. This is not painful.
- After around 10 minutes of sitting quietly, the investigator will inflate a blood pressure cuff around the arm that the array is placed on. This will temporarily prevent blood entering or leaving the arm. This will feel tight and the arm may go numb. The investigator will keep the cuff inflated for five minutes, but the participant can ask for the cuff to be deflated at any time.
- The investigator will then deflate the cuff, allowing blood back into the arm. After around 10 more minutes, the investigator will remove the cuff and array and the participant will be free to leave.
Once the angiogram is performed (as part of their routine clinical care) the results will be reviewed by a clinically trained researcher. This will then be correlated with their vascular function measured by DOT to determine whether this can predict angiographic findings.
- Conditions
- Atherosclerosis, Diabetes, Coronary Artery Disease
- Being tested
- diffuse optical tomography
- Medical subject headings
- Atherosclerosis, Diabetes Mellitus, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffuse optical tomographyDevice
Optical tomography is a form of computed tomography that creates a digital volumetric model of an object by reconstructing images made from light transmitted and scattered through an object.
| Study group | Role | What they receive |
|---|---|---|
| Vascular function | Experimental | Diffuse optical tomography detection of differences in vascular function between healthy volunteers and patients with proven heart disease or diabetes. Receives: Device: diffuse optical tomography |
| Coronary artery disease | Experimental | Diffuse optical tomography prediction of presence or severity of coronary artery disease on angiography. Receives: Device: diffuse optical tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can diffuse optical tomography detect microvascular function?
Measuring microvascular function with diffuse optical tomography
Measured: 3 years from start date
Secondary outcomes (3)
Detecting differences in microvascular function in atherosclerosis
Detecting differences in microvascular function using diffuse optical tomography between healthy people and those with atherosclerosis
Measured: 3 years from start date
Detecting differences in microvascular function in diabetes
Detecting differences in microvascular function using diffuse optical tomography between healthy people and those with diabetes
Measured: 3 years from start date
Predicting coronary artery disease before angiography
Predicting coronary artery disease before angiography using diffuse optical tomography
Measured: 3 years from start date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start11 Jan 2016
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
- Investigators
- Timothy Chico, Principal investigator, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411213
- Sponsor's protocol ID
- STH18094
- Acronym
- DOT
- Status last verified
- May 2022
- First submitted
- 18 Dec 2017
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marzilli M, Merz CN, Boden WE, Bonow RO, Capozza PG, Chilian WM, DeMaria AN, Guarini G, Huqi A, Morrone D, Patel MR, Weintraub WS. Obstructive coronary atherosclerosis and ischemic heart disease: an elusive link! J Am Coll Cardiol. 2012 Sep 11;60(11):951-6. doi: 10.1016/j.jacc.2012.02.082.
PubMed 22954239Tooke JE. Microvascular function in human diabetes. A physiological perspective. Diabetes. 1995 Jul;44(7):721-6. doi: 10.2337/diab.44.7.721.
PubMed 7789639Pyke KE, Tschakovsky ME. Peak vs. total reactive hyperemia: which determines the magnitude of flow-mediated dilation? J Appl Physiol (1985). 2007 Apr;102(4):1510-9. doi: 10.1152/japplphysiol.01024.2006. Epub 2006 Dec 14.
PubMed 17170205Charakida M, Masi S, Luscher TF, Kastelein JJ, Deanfield JE. Assessment of atherosclerosis: the role of flow-mediated dilatation. Eur Heart J. 2010 Dec;31(23):2854-61. doi: 10.1093/eurheartj/ehq340. Epub 2010 Sep 23.
PubMed 20864485Huang AL, Silver AE, Shvenke E, Schopfer DW, Jahangir E, Titas MA, Shpilman A, Menzoian JO, Watkins MT, Raffetto JD, Gibbons G, Woodson J, Shaw PM, Dhadly M, Eberhardt RT, Keaney JF Jr, Gokce N, Vita JA. Predictive value of reactive hyperemia for cardiovascular events in patients with peripheral arterial disease undergoing vascular surgery. Arterioscler Thromb Vasc Biol. 2007 Oct;27(10):2113-9. doi: 10.1161/ATVBAHA.107.147322. Epub 2007 Aug 23.
PubMed 17717291Mitchell GF, Parise H, Vita JA, Larson MG, Warner E, Keaney JF Jr, Keyes MJ, Levy D, Vasan RS, Benjamin EJ. Local shear stress and brachial artery flow-mediated dilation: the Framingham Heart Study. Hypertension. 2004 Aug;44(2):134-9. doi: 10.1161/01.HYP.0000137305.77635.68. Epub 2004 Jul 12.
PubMed 15249547Rubinshtein R, Kuvin JT, Soffler M, Lennon RJ, Lavi S, Nelson RE, Pumper GM, Lerman LO, Lerman A. Assessment of endothelial function by non-invasive peripheral arterial tonometry predicts late cardiovascular adverse events. Eur Heart J. 2010 May;31(9):1142-8. doi: 10.1093/eurheartj/ehq010. Epub 2010 Feb 24.
PubMed 20181680Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41. doi: 10.1016/j.jacc.2004.08.062.
PubMed 15582310Dhawan AP, D'Alessandro B, Fu X. Optical imaging modalities for biomedical applications. IEEE Rev Biomed Eng. 2010;3:69-92. doi: 10.1109/RBME.2010.2081975.
PubMed 22275202Takagishi Y, Yamamura H. Purkinje cell abnormalities and synaptogenesis in genetically jaundiced rats (Gunn rats). Brain Res. 1989 Jul 17;492(1-2):116-28. doi: 10.1016/0006-8993(89)90894-9.
PubMed 2752293
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Assessment and Characterization of Microvascular Function Using Diffuse Optical Tomography Version
- ClinicalTrials.gov ID
- NCT03411213
- Acronym / sponsor ID
- DOT / STH18094
- Conditions
- Atherosclerosis, Diabetes, Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- 11 Jan 2016 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 26 Jan 2018 (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.
Atherosclerosis is accompanied by microvascular dysfunction (an impairment of blood vessels to dilate or constrict in response to demand). The ability to reliably measure microvascular dysfunction would help identify patients at risk of myocardial infarction and test new treatments. All existing measures of microvascular dysfunction suffer significant limitations.
Near Infrared Spectroscopy (NIRS) is an imaging method that uses an infrared light-source and detector (called optodes) to painlessly shines light into tissue and collect reflected light at different wavelengths. This data allows quantification of the amount of haemoglobin (blood) in the tissue and whether it is oxygenated or de-oxygenated.
Diffuse optical tomography (DOT) is a powerful analysis technique for data collected from multiple NIRH optodes. Unlike most NIRS studies that use a single pair of optodes and collects a single datapoint for each wavelength over time, DOT allows three-dimensional spatial reconstruction of haemodynamic and anatomic changes in a large region of tissue over time.
In preliminary work DOT had the potential to measure forearm reactive hyperaemia, a key indicator of microvascular function. Team will test whether DOT can detect differences between patients and healthy volunteers.
In this work, 30 patients will be recruited with type 2 diabetes, 30 patients who have had a previous myocardial infarction and 30 healthy volunteers. The Investigator will also recruit 50 patients who are on waiting lists for coronary angiography.
The DOT will be used to measure participants' microvascular function after brachial artery occlusion by a blood pressure cuff. The Investigator will then examine whether DOT can detect differences between healthy volunteers, diabetics, and patients with a previous heart attack, and whether DOT is able to predict existence of coronary artery disease on angiography. If successful, DOT can be developed for assessment of microvascular function to the point where it could be applied to clinical studies.
Detailed description
Previous pilot studies have shown ability to collect promising data safely. In the following studies, the same study as in the pilot will be performed to apply the array of optodes to the surface of the arm. These emit light painlessly into the tissue and collect scattered light from the tissue. Inflation of a blood pressure cuff around the arm for 5 minutes, then deflate the cuff to allow blood flow back into the tissue. From the data gathered before, during and after the cuff is inflated, 3D reconstructions can be performed of HbO, HbR, and HbT changes in the forearm during and after arterial occlusion.
Study 1) Can DOT detect differences in vascular function between healthy volunteers and patients with proven heart disease or diabetes
This study will measure vascular function in patients with known heart disease (previous myocardial infarction) or diabetes and compare this to matched healthy volunteers. This will establish whether DOT can detect differences in vascular response between these groups. If so, then the method has the potential to be useful diagnostically or prognostically.
Potential participants will be approached by poster, or face to face in STH clinics and provided with the information sheet which participants will be asked to read at home. Participants will be given the opportunity to ask questions by email or telephone at any time afterwards. Participants will be asked to contact us if they are willing to participate.
Participants will be booked with an appointment to attend the Clinical Research Facility at Sheffield Teaching Hospitals (at least 24hrs after receiving the information sheet and having the chance to ask questions) for a visit of 30-45 minutes. Visits will be arranged in advance at a convenient time.
When participants attend, after agreeing to take part and signing a consent form, participants will take a seat in a private room. Participants will need to wear short sleeves, or roll their sleeves up. If necessary, the investigator can provide a gown to wear if the sleeves are too tight. The investigator will then do the following;
- Record some details about medical history, height/weight, whether they take medications, date of birth, whether male or female.
- Measure the blood pressure by briefly inflating a cuff around the upper arm.
- Place an array of fibre optics on the surface of the forearm. Some jelly will be placed on the skin first, and the array will be held in place by a strap or tape. This is not painful.
- After around 10 minutes of sitting quietly, the investigator will inflate a blood pressure cuff around the arm that the array is placed on. This will temporarily prevent blood entering or leaving the arm. This will feel tight and the arm may go numb. The investigator will keep the cuff inflated for five minutes, but the participant can ask for the cuff to be deflated at any time.
- The investigator will then deflate the cuff, allowing blood back into the arm. After around 10 more minutes, the investigator will remove the cuff and array and the participant will be free to leave.
After the first assessment, the investigator will ask participants if they would be willing to attend for a second assessment where we would repeat the above measurements. This is to test how reproducible the measurements are in the same individual.
Study 2) Can DOT predict presence or severity of coronary artery disease on angiography?
This study will measure vascular function in patients awaiting diagnostic coronary angiography (either invasive or by CT), in whom it is not known whether or not coronary artery disease is present. Once the angiographic results are available the investigator will correlate vascular function measured by DOT with presence and severity of coronary artery disease to examine whether or not DOT identified
Potential participants will be approached by poster, or face to face in STH clinics and provided with the information sheet which participants will be asked to read. Participants will be given the opportunity to ask questions by email or telephone at any time afterwards. Participants will be asked to contact us if they are willing to participate.
Participants will be booked with an appointment to attend the Clinical Research Facility at Sheffield Teaching Hospitals (at least 24hrs after receiving the information sheet and having the chance to ask questions) for a visit of approximately 45 minutes. Visits will be arranged in advance at a convenient time.
When participants attend, after agreeing to take part and signing a consent form, particpants will take a seat in a private room. Participants will need to wear short sleeves, or roll their sleeves up. If necessary, the investigator can provide a gown to wear if the sleeves are too tight. the investigator will then do the following;
- Record some details about medical history, whether they take medications, date of birth, whether male or female.
- Measure the blood pressure by briefly inflating a cuff around the upper arm.
- Place an array of fibre optics on the surface of the forearm. Some jelly will be placed on the skin first, and the array will be held in place by a strap or tape. This is not painful.
- After around 10 minutes of sitting quietly, the investigator will inflate a blood pressure cuff around the arm that the array is placed on. This will temporarily prevent blood entering or leaving the arm. This will feel tight and the arm may go numb. The investigator will keep the cuff inflated for five minutes, but the participant can ask for the cuff to be deflated at any time.
- The investigator will then deflate the cuff, allowing blood back into the arm. After around 10 more minutes, the investigator will remove the cuff and array and the participant will be free to leave.
Once the angiogram is performed (as part of their routine clinical care) the results will be reviewed by a clinically trained researcher. This will then be correlated with their vascular function measured by DOT to determine whether this can predict angiographic findings.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vascular function | Experimental | Device: diffuse optical tomographyDiffuse optical tomography detection of differences in vascular function between healthy volunteers and patients with proven heart disease or diabetes. |
| Coronary artery disease | Experimental | Device: diffuse optical tomographyDiffuse optical tomography prediction of presence or severity of coronary artery disease on angiography. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-80 of either sex
- Ability to read and speak English to a level allowing understanding of the patient information and to give consent to participate
- Diagnosed as type 2 diabetic for at least 12 months
- No painful arms or health problems preventing blood pressure cuff inflation
- No lymphoedema of the arm
Key exclusion criteria (1 listed)
- Any patients that do not meet the above criteria will be excluded
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 |
|---|---|---|
| diffuse optical tomographyOptical tomography is a form of computed tomography that creates a digital volumetric model of an object by reconstructing images made from light transmitted and scattered through an object. | Device | Coronary artery disease, Vascular function |
Primary outcome
Can diffuse optical tomography detect microvascular function?
Time frame: 3 years from start date
Measuring microvascular function with diffuse optical tomography
3 secondary outcomes
Detecting differences in microvascular function in atherosclerosis
Time frame: 3 years from start date
Detecting differences in microvascular function in diabetes
Time frame: 3 years from start date
Predicting coronary artery disease before angiography
Time frame: 3 years from start date
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 17 May 2022.
- Background: PubMed 22954239Marzilli M, Merz CN, Boden WE, Bonow RO, Capozza PG, Chilian WM, DeMaria AN, Guarini G, Huqi A, Morrone D, Patel MR, Weintraub WS. Obstructive coronary atherosclerosis and ischemic heart disease: an elusive link! J Am Coll Cardiol. 2012 Sep 11;60(11):951-6. doi: 10.1016/j.jacc.2012.02.082.
- Background: PubMed 7789639Tooke JE. Microvascular function in human diabetes. A physiological perspective. Diabetes. 1995 Jul;44(7):721-6. doi: 10.2337/diab.44.7.721.
- Background: PubMed 17170205Pyke KE, Tschakovsky ME. Peak vs. total reactive hyperemia: which determines the magnitude of flow-mediated dilation? J Appl Physiol (1985). 2007 Apr;102(4):1510-9. doi: 10.1152/japplphysiol.01024.2006. Epub 2006 Dec 14.
- Background: PubMed 20864485Charakida M, Masi S, Luscher TF, Kastelein JJ, Deanfield JE. Assessment of atherosclerosis: the role of flow-mediated dilatation. Eur Heart J. 2010 Dec;31(23):2854-61. doi: 10.1093/eurheartj/ehq340. Epub 2010 Sep 23.
- Background: PubMed 17717291Huang AL, Silver AE, Shvenke E, Schopfer DW, Jahangir E, Titas MA, Shpilman A, Menzoian JO, Watkins MT, Raffetto JD, Gibbons G, Woodson J, Shaw PM, Dhadly M, Eberhardt RT, Keaney JF Jr, Gokce N, Vita JA. Predictive value of reactive hyperemia for cardiovascular events in patients with peripheral arterial disease undergoing vascular surgery. Arterioscler Thromb Vasc Biol. 2007 Oct;27(10):2113-9. doi: 10.1161/ATVBAHA.107.147322. Epub 2007 Aug 23.
- Background: PubMed 15249547Mitchell GF, Parise H, Vita JA, Larson MG, Warner E, Keaney JF Jr, Keyes MJ, Levy D, Vasan RS, Benjamin EJ. Local shear stress and brachial artery flow-mediated dilation: the Framingham Heart Study. Hypertension. 2004 Aug;44(2):134-9. doi: 10.1161/01.HYP.0000137305.77635.68. Epub 2004 Jul 12.
- Background: PubMed 20181680Rubinshtein R, Kuvin JT, Soffler M, Lennon RJ, Lavi S, Nelson RE, Pumper GM, Lerman LO, Lerman A. Assessment of endothelial function by non-invasive peripheral arterial tonometry predicts late cardiovascular adverse events. Eur Heart J. 2010 May;31(9):1142-8. doi: 10.1093/eurheartj/ehq010. Epub 2010 Feb 24.
- Background: PubMed 15582310Bonetti PO, Pumper GM, Higano ST, Holmes DR Jr, Kuvin JT, Lerman A. Noninvasive identification of patients with early coronary atherosclerosis by assessment of digital reactive hyperemia. J Am Coll Cardiol. 2004 Dec 7;44(11):2137-41. doi: 10.1016/j.jacc.2004.08.062.
- Background: PubMed 22275202Dhawan AP, D'Alessandro B, Fu X. Optical imaging modalities for biomedical applications. IEEE Rev Biomed Eng. 2010;3:69-92. doi: 10.1109/RBME.2010.2081975.
- Background: PubMed 2752293Takagishi Y, Yamamura H. Purkinje cell abnormalities and synaptogenesis in genetically jaundiced rats (Gunn rats). Brain Res. 1989 Jul 17;492(1-2):116-28. doi: 10.1016/0006-8993(89)90894-9.
- Individual participant dataSharing planned: Undecided
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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.
Timothy Chico principal investigator
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diffuse optical tomography in people with Atherosclerosis and Diabetes, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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 6 inclusion and 1 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 17 May 2022. 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 United Kingdom. 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?
Can diffuse optical tomography detect microvascular function? (time frame: 3 years from start date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03411213, which also lists 10 linked publications.
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 17 May 2022.