HAT: Hand Acceleration Time Assessment With Ultrasound Doppler

Sponsor
Hospital Universitari de Bellvitge (Other)
Overall Status
Recruiting
CT.gov ID
NCT05977725
Collaborator
(none)
35
1
5
7

Study Details

Study Description

Brief Summary

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 noninvasive, 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 Doppler 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 is defined as the time elapsed from the beginning of the arterial wave until reaching its peak systolic velocity.

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.

Although the acceleration time parameter has also been studied in other territories (e.g., the carotid and pulmonary arteries, coronary arteries, and the aorta), there is no evidence regarding the hand territory. The present study aims to fill this gap.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Hand Doppler Ultrasound

Study Design

Study Type:
Observational
Anticipated Enrollment :
35 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Hemodynamic Assessment of the Hand Arterial Perfusion Through the Ultrasound-Doppler Hand Acceleration Time (HAT) Technique: A Descriptive Study
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Healthy Volunteers

Lack of upper limb arterial disease.

Diagnostic Test: Hand Doppler Ultrasound
Hand Doppler Ultrasound to assess the Hand Acceleration Time (HAT)

Patients with Chronic Upper Limb Ischemia

Known diagnosis of chronic upper limb ischemia.

Diagnostic Test: Hand Doppler Ultrasound
Hand Doppler Ultrasound to assess the Hand Acceleration Time (HAT)

Outcome Measures

Primary Outcome Measures

  1. Median (range) hand acceleration time measured by Doppler ultrasound [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

Secondary Outcome Measures

  1. Median (range) age of the participants. [Day 1]

  2. Number (percentage) of male/female participants. [Day 1]

  3. Number (percentage) of patients presenting cardiovascular risk factors of interest. [Day 1]

    Cardiovascular risk factors of interest are smoking habits, arterial hypertension, diabetes mellitus, and dyslipidemia).

  4. Number (percentage) of patients with past medical history of interest. [Day 1]

    A past medical history of interest is defined as ischemic cardiopathy, heart failure, and chronic obstructive pulmonary disease.

  5. Presence (Yes/No) of distal pulses in the upper limb. [Day 1]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitari de Bellvitge L'Hospitalet De Llobregat Barcelona Spain 08907

Sponsors and Collaborators

  • Hospital Universitari de Bellvitge

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Begoña Gonzalo Villanueva, Expert Vascular Surgeon, Hospital Universitari de Bellvitge
ClinicalTrials.gov Identifier:
NCT05977725
Other Study ID Numbers:
  • 1 - VASC - 2023
First Posted:
Aug 4, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Begoña Gonzalo Villanueva, Expert Vascular Surgeon, Hospital Universitari de Bellvitge
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 8, 2023