- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05977725
Hand Acceleration Time Assessment With Ultrasound Doppler (HAT)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Barcelona
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L'Hospitalet De Llobregat, Barcelona, Spain, 08907
- Hospital Universitari de Bellvitge
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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.
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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:
|
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
|
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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
|
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Presence (Yes/No) of distal pulses in the upper limb.
Time Frame: Day 1
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Day 1
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Sommerset J, Karmy-Jones R, Dally M, Feliciano B, Vea Y, Teso D. Plantar Acceleration Time: A Novel Technique to Evaluate Arterial Flow to the Foot. Ann Vasc Surg. 2019 Oct;60:308-314. doi: 10.1016/j.avsg.2019.03.002. Epub 2019 May 8.
- Teso D, Sommerset J, Dally M, Feliciano B, Vea Y, Jones RK. Pedal Acceleration Time (PAT): A Novel Predictor of Limb Salvage. Ann Vasc Surg. 2021 Aug;75:189-193. doi: 10.1016/j.avsg.2021.02.038. Epub 2021 Apr 3.
- Strosberg DS, Haurani MJ, Satiani B, Go MR. Common carotid artery end-diastolic velocity and acceleration time can predict degree of internal carotid artery stenosis. J Vasc Surg. 2017 Jul;66(1):226-231. doi: 10.1016/j.jvs.2017.01.041. Epub 2017 Apr 5.
- Wang S, Wang Y, Gao M, Tan Y. Acceleration time to Ejection time ratio in fetal pulmonary artery system can predict neonatal respiratory disorders in gestational diabetic mellitus women. Clin Hemorheol Microcirc. 2022;80(4):497-507. doi: 10.3233/CH-211265.
- Takemoto K, Hirata K, Wada N, Shiono Y, Komukai K, Tanimoto T, Ino Y, Kitabata H, Takarada S, Nakamura N, Kubo T, Tanaka A, Imanishi T, Akasaka T. Acceleration time of systolic coronary flow velocity to diagnose coronary stenosis in patients with microvascular dysfunction. J Am Soc Echocardiogr. 2014 Feb;27(2):200-7. doi: 10.1016/j.echo.2013.10.013. Epub 2013 Dec 15.
- Zarzecki MP, Popieluszko P, Zayachkowski A, Pekala PA, Henry BM, Tomaszewski KA. The surgical anatomy of the superficial and deep palmar arches: A Meta-analysis. J Plast Reconstr Aesthet Surg. 2018 Nov;71(11):1577-1592. doi: 10.1016/j.bjps.2018.08.014. Epub 2018 Aug 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1 - VASC - 2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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