Detecting Circulating Emboli in Patients with Acute Venous Thromboembolism

NCT ID: NCT02735759

Last Updated: 2024-09-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2018-07-01

Brief Summary

The purpose of this study is to further evaluate and adjust the photoacoustic flow cytometry device and its use in detecting circulating emboli.

Study Design: Cohort 1: Normal healthy volunteers will be enrolled to further adjust the device settings. Cohort 2: Use the Phatoacoustic flow cytometry (PAFC) to detect circulating emboli in vivo in patients with venous thromboembolism at diagnosis, during and after anticoagulation therapy.

Detailed Description

Laser beam from the investigational device Phatoacoustic flow cytometry PAFC will be applied to skin and underlying blood vessels. The optical and ultrasound signal will be collected for analysis. On each tested vessel, we will estimate the vessels diameter (using optical or/and ultrasound imaging). The subject's skin pigmentation will be classified as light, medium, or dark. A photoacoustic (PA) contrast will be considered usable for detection of circulating emboli if the photoacoustic signal from the vessels is more than 1.3-fold higher than the photoacoustic signal from surrounding tissue. The device for subjects enrolled on cohort 2 will be completed on day 0 (immediately after venous thromboembolism diagnosis and prior to anticoagulation therapy), day 7 ± 3 days after initiation of anticoagulation therapy, one week ± 3 days after completion of planned anticoagulation therapy and one month ± 3 days after completion of planned anticoagulation therapy. Anticoagulation therapy is part of the patient's normal standard of care and is not part of this study however data from what therapy was received may be captured. D-dimer test will be performed on each time point as part of their normal standard of care however if the D-dimer test is not ordered as part of the standard of care it will be required for the study.. Patients will then be followed in hematology clinic to monitor the venous thromboembolism recurrence every 3 months for one year.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Healthy Volunteers

This cohort will consist of ten healthy volunteers. The photoacoustic flow cytometry device will be used to establish device settings. The intervention with the subject will include the PAFC device to establish appropriate device settings.

Group Type: OTHER

Photoacoustic flow cytometry device

Intervention Type: DEVICE

The device for subjects enrolled on cohort 2 will be completed on day 0 (immediately after venous thromboembolism diagnosis and prior to anticoagulation therapy), day 7 ± 3 days after initiation of anticoagulation therapy, one week ± 3 days after completion of planned anticoagulation therapy and one month ± 3 days after completion of planned anticoagulation therapy. Anticoagulation therapy is part of the patient's normal standard of care and is not part of this study however data from what therapy was received may be captured. Patients will then be followed in hematology clinic to monitor the venous thromboembolism recurrence every 3 months for one year.

Venous Thromboembolism

This cohort will consist of ten patients with newly diagnosed, non-life threatening acute venous thromboembolism. The intervention with the subjects is to perform the photoacoustic flow cytometry device to detect circulating emboli in vivo in patients with venous thromboembolism at diagnosis, during and after anticoagulation therapy.

Group Type: OTHER

Photoacoustic flow cytometry device

Intervention Type: DEVICE

The device for subjects enrolled on cohort 2 will be completed on day 0 (immediately after venous thromboembolism diagnosis and prior to anticoagulation therapy), day 7 ± 3 days after initiation of anticoagulation therapy, one week ± 3 days after completion of planned anticoagulation therapy and one month ± 3 days after completion of planned anticoagulation therapy. Anticoagulation therapy is part of the patient's normal standard of care and is not part of this study however data from what therapy was received may be captured. Patients will then be followed in hematology clinic to monitor the venous thromboembolism recurrence every 3 months for one year.

Interventions

Photoacoustic flow cytometry device

The device for subjects enrolled on cohort 2 will be completed on day 0 (immediately after venous thromboembolism diagnosis and prior to anticoagulation therapy), day 7 ± 3 days after initiation of anticoagulation therapy, one week ± 3 days after completion of planned anticoagulation therapy and one month ± 3 days after completion of planned anticoagulation therapy. Anticoagulation therapy is part of the patient's normal standard of care and is not part of this study however data from what therapy was received may be captured. Patients will then be followed in hematology clinic to monitor the venous thromboembolism recurrence every 3 months for one year.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18 years and older
• Willing to adhere to protocol.
• Signed informed consent

• Ages 18 years and older
• Confirmed new diagnosis of acute venous thromboembolism.
• performance status of equal to or less than 2.
• Able to receive anticoagulation therapy.
• Willing to adhere to specific protocol requirements.
• Signed informed consent.

Exclusion Criteria

• Unable to provide informed consent.
• History of venous thromboembolism.
• Currently receiving anticoagulant therapy.

• Life threatening venous thromboembolism.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhifu Xiang, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Other Identifiers

205341.

Identifier Type: -

Identifier Source: org_study_id