Clinical trial NCT05301348: In Vivo Detection of Circulating Clots in Patients With Thromboembolism
Official title: In Vivo Detection of Circulating Clots in Patients With Thromboembolism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Thromboembolism
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2022-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria

* Men and women, 18 years old and older.
* Evidence of current venous or arterial thromboembolic disease diagnosed by standard of care clinical, radiographic, or laboratory testing or acute ischemic stroke.
* Informed consent provided by the subject.

Exclusion Criteria

* Pulmonary embolus with a need for mechanical ventilation or other ventilator support (may be on oxygen delivered by nasal cannula or mask at an FiO2 of ≤ 0.40)
* Acute coronary syndrome (including unstable angina)
* Significant cardiac arrhythmia (may have atrial fibrillation controlled with medication)
* Intracardiac thrombus
* Any embolus or thrombus requiring vascular surgery or interventional radiology to attempt acute embolectomy or thrombectomy
* Sickle cell disease with vaso-occlusive crisis
* Sepsis or life-threatening infection
* Traumatic injury requiring hospitalization (within 30 days prior to enrollment)
* Pregnancy or breastfeeding
* Severe mental illness
* Other conditions deemed by the investigators to put the subject at greater risk

Primary outcomes:
measure: Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Positive PA peaks
timeFrame: 30 days
measure: Comparison of Circulating blood clots detected by PAFC with D-dimer levels in patients with known venous thromboembolic disease - Negative PA peaks
timeFrame: 30 days
Secondary outcomes:
measure: Relationship between PA peaks and circulating blood clots
timeFrame: 30 days
measure: Safety of the PAFC method - skin sensitivity
timeFrame: 30 days
measure: Safety of the PAFC method - change in skin property
timeFrame: 30 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Univerisity of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Sanjeeva Onteddu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Arkansas
name: Jonathan A Young
role: STUDY_DIRECTOR
References:
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citation: 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.
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