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Subjects with thromboembolic disease or at high-risk for thromboembolic conditions diagnosed with ultrasound or other standard of care techniques will be recruited to estimate the feasibility of a device to detect in vivo CBCs.
There are no current gold standards to detect circulating blood clots. The sensitivity of most current methods to detect CBCs is poor when low numbers are present in the host. A novel method of detecting circulating blood clots, PAFC, may improve detection of CBCs and, if so, ultimately may reduce complications related to previously undetected clots.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedure | Experimental | Subjects will receive PAFC procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photoacoustic Flow Cytometry | Device | Detection of circulating blood clots |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Positive PA peaks | Measurement of in vivo CBC-associated positive PA peaks in a signal trace of patients who have been diagnosed with conventional methods. | 30 days |
| Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Negative PA peaks | Measurement of in vivo CBC-associated negative PA peaks in a signal trace of patients who have been diagnosed with conventional methods. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship between PA peaks and circulating blood clots | PAFC will be compared with the fibrin degradation fragment D-dimer to indicate the presence of a blood clot undergoing dissolution. | 30 days |
| Safety of the PAFC method - skin sensitivity |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sanjeeva Onteddu, MD | Contact | 5016865135 | sronteddu@uams.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sanjeeva Onteddu, MD | University of Arkansas | Principal Investigator |
| Jonathan A Young | University of Arkansas | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univerisity of Arkansas for Medical Sciences | Recruiting | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19411875 | Background | Dressler DK. Death by clot: acute coronary syndromes, ischemic stroke, pulmonary embolism, and disseminated intravascular coagulation. AACN Adv Crit Care. 2009 Apr-Jun;20(2):166-76. doi: 10.1097/NCI.0b013e3181a0b5e8. | |
| 22903924 | Background | Nedosekin DA, Sarimollaoglu M, Galanzha EI, Sawant R, Torchilin VP, Verkhusha VV, Ma J, Frank MH, Biris AS, Zharov VP. Synergy of photoacoustic and fluorescence flow cytometry of circulating cells with negative and positive contrasts. J Biophotonics. 2013 May;6(5):425-34. doi: 10.1002/jbio.201200047. Epub 2012 Aug 20. |
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| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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The safety of the PAFC device through estimation of the sensitivity of the individual's skin to laser radiation will be indicated by a possible warming feeling or tingling sensation.
| 30 days |
| Safety of the PAFC method - change in skin property | The safety of the PAFC device through estimation of the change to the skin's property after laser exposure measured by appearance of possible red spots in the irradiated local area | 30 days |
| 30460154 | Background | Juratli MA, Menyaev YA, Sarimollaoglu M, Melerzanov AV, Nedosekin DA, Culp WC, Suen JY, Galanzha EI, Zharov VP. Noninvasive label-free detection of circulating white and red blood clots in deep vessels with a focused photoacoustic probe. Biomed Opt Express. 2018 Oct 23;9(11):5667-5677. doi: 10.1364/BOE.9.005667. eCollection 2018 Nov 1. |
| 17433897 | Background | Cushman M. Epidemiology and risk factors for venous thrombosis. Semin Hematol. 2007 Apr;44(2):62-9. doi: 10.1053/j.seminhematol.2007.02.004. |
| 16102026 | Background | Heit JA. Venous thromboembolism: disease burden, outcomes and risk factors. J Thromb Haemost. 2005 Aug;3(8):1611-7. doi: 10.1111/j.1538-7836.2005.01415.x. |
| 2025141 | Background | Anderson FA Jr, Wheeler HB, Goldberg RJ, Hosmer DW, Patwardhan NA, Jovanovic B, Forcier A, Dalen JE. A population-based perspective of the hospital incidence and case-fatality rates of deep vein thrombosis and pulmonary embolism. The Worcester DVT Study. Arch Intern Med. 1991 May;151(5):933-8. |
| 27227413 | Background | Juratli MA, Menyaev YA, Sarimollaoglu M, Siegel ER, Nedosekin DA, Suen JY, Melerzanov AV, Juratli TA, Galanzha EI, Zharov VP. Real-Time Label-Free Embolus Detection Using In Vivo Photoacoustic Flow Cytometry. PLoS One. 2016 May 26;11(5):e0156269. doi: 10.1371/journal.pone.0156269. eCollection 2016. |
| 21976458 | Background | Galanzha EI, Sarimollaoglu M, Nedosekin DA, Keyrouz SG, Mehta JL, Zharov VP. In vivo flow cytometry of circulating clots using negative photothermal and photoacoustic contrasts. Cytometry A. 2011 Oct;79(10):814-24. doi: 10.1002/cyto.a.21106. Epub 2011 Aug 16. |
| 22749928 | Background | Galanzha EI, Zharov VP. Photoacoustic flow cytometry. Methods. 2012 Jul;57(3):280-96. doi: 10.1016/j.ymeth.2012.06.009. Epub 2012 Jun 26. |