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Hand Acceleration Time Assessment With Ultrasound Doppler (HAT)

C

Catalan Institute of Health

Status

Active, not recruiting

Conditions

Vascular Disease
Upper Limb Ischemia

Treatments

Diagnostic Test: Hand Doppler Ultrasound

Study type

Observational

Funder types

Other

Identifiers

NCT05977725
1 - VASC - 2023

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

35 participants in 2 patient groups

Healthy Volunteers
Description:
Lack of upper limb arterial disease.
Treatment:
Diagnostic Test: Hand Doppler Ultrasound
Patients with Chronic Upper Limb Ischemia
Description:
Known diagnosis of chronic upper limb ischemia.
Treatment:
Diagnostic Test: Hand Doppler Ultrasound

Trial contacts and locations

1

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Central trial contact

Sebastián Videla, MD, PhD; Begoña Gonzalo, MD

Data sourced from clinicaltrials.gov

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