Hand Acceleration Time Assessment With Ultrasound Doppler (HAT)

January 10, 2024 updated by: Begoña Gonzalo Villanueva, Hospital Universitari de Bellvitge

Hemodynamic Assessment of the Hand Arterial Perfusion Through the Ultrasound-Doppler Hand Acceleration Time (HAT) Technique: A Descriptive Study

Chronic upper limb ischemia syndrome is uncommon compared to lower limb ischemia, with several potential causes (e.g., arteriosclerosis, compressive syndromes, arteritis, connective tissue diseases, trauma, and thrombosis). Many patients with upper limb ischemia remain asymptomatic due to arterial collateral vascularization.

Given the wide variety of potential causes for upper limb ischemia, the diagnosis may require different technical approaches. Doppler ultrasound is a non-invasive, accessible, non-radiating technique that provides direct arterial imaging, yielding valuable information on arterial anatomy and hemodynamics.

Some authors have described the reliability of the arterial duplex ultrasound for lower limb assessment using the pedal acceleration time (PAT). The PAT provides real-time hemodynamic physiological information on the entire limb. The acceleration time (AT) is an ultrasound parameter which measures the time elapsed (in milliseconds, ms) from the beginning of the arterial Doppler waveform until the systolic peak, evaluating the morphology of the arterial waveform in real time. In a healthy individual, this time should be short (between 40 - 100 milliseconds), displaying a triphasic waveform with a systolic acceleration, a sudden diastolic fall, and a subsequent anterograde flow at the end of diastole. A more damped wave suggests proximal stenosis and the acceleration time has been correlated to different degrees of foot ischemia.

Notably, the AT parameter has also been studied in other territories, such as the carotid and pulmonary arteries, coronary arteries, and the aorta. Hand acceleration time (HAT) has also been described very recently as a potential tool to assess hemodialysis access-induced ischemia, cardiogenic shock, and subclavian iatrogenic ischemic lesion. However, the HAT has not yet been properly characterized or validated. Our working hypothesis is that the HAT is a useful diagnostic tool for chronic upper limb ischemia.

Study Overview

Status

Active, not recruiting

Study Type

Observational

Enrollment (Estimated)

35

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

    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of healthy volunteers accompanying patients to the Angiology and Vascular Surgery outpatient clinic visit and patients diagnosed with chronic upper limb ischemia. Both will be required to sign the written informed consent before joining the study.

Description

Inclusion Criteria (healthy volunteers):

  • Healthy adult volunteers (≥ 18 years of age).
  • No evidence of upper limb arterial disease.
  • Who sign the written informed consent.

Exclusion Criteria (healthy volunteers):

  • Healthy volunteers unable (at the investigator discretion) to understand or comply with any study-related procedure.
  • Healthy volunteers who refuse to participate.
  • Those presenting cardiovascular risk factors (e.g., hypertension, diabetes mellitus, dyslipidemia).

Inclusion Criteria (upper limb ischemia patients):

  • Adult patients (≥ 18 years of age) with a known diagnosis of chronic upper limb ischemia.
  • Who sign the written informed consent.

Exclusion Criteria (upper limb ischemia patients):

  • Patients unable (at the investigator discretion) to understand or comply with any study-related procedure.
  • Patients who refuse to participate.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Volunteers
Lack of upper limb arterial disease.
Hand Doppler Ultrasound to assess the Hand Acceleration Time (HAT)
Patients with Chronic Upper Limb Ischemia
Known diagnosis of chronic upper limb ischemia.
Hand Doppler Ultrasound to assess the Hand Acceleration Time (HAT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median (range) hand acceleration time measured by Doppler ultrasound
Time Frame: Day 1

The hand acceleration time will be measured at the following arteries:

  • Distal radial artery
  • Distal ulnar artery
  • Princeps pollicis artery
  • Index finger radial artery
  • Second common palmar digital artery
  • Fourth common palmar digital artery
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median (range) age of the participants.
Time Frame: Day 1
Day 1
Number (percentage) of male/female participants.
Time Frame: Day 1
Day 1
Number (percentage) of patients presenting cardiovascular risk factors of interest.
Time Frame: Day 1
Cardiovascular risk factors of interest are smoking habits, arterial hypertension, diabetes mellitus, and dyslipidemia).
Day 1
Number (percentage) of patients with past medical history of interest.
Time Frame: Day 1
A past medical history of interest is defined as ischemic cardiopathy, heart failure, and chronic obstructive pulmonary disease.
Day 1
Presence (Yes/No) of distal pulses in the upper limb.
Time Frame: Day 1
Day 1

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2023

Primary Completion (Actual)

September 30, 2023

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 1 - VASC - 2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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