Detecting Circulating Emboli in Patients with Acute Venous Thromboembolism (PAFC)

August 29, 2024 updated by: University of Arkansas

Detecting Circulating Emboli in Patients with Acute Venous Thromboembolism Using in Vivo Photoacoustic Flow Cytometry (PAFC)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria Cohort 1:

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

Exclusion Criteria Cohort 1:

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

Inclusion Criteria Cohort 2:

  • 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 Cohort 2:

  • Life threatening venous thromboembolism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 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.
Device: 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.
Other: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of subjects that posses circulating emboli.
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Arkansas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhifu Xiang, MD, University of Arkansas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 1, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 205341.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data learned from this study will be published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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