Clinical trial NCT05977725: Hand Acceleration Time Assessment With Ultrasound Doppler
Official title: Hemodynamic Assessment of the Hand Arterial Perfusion Through the Ultrasound-Doppler Hand Acceleration Time (HAT) Technique: A Descriptive Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Upper Limb Ischemia
Vascular Disease
Keywords: Hand acceleration time
Upper limb ischemia
Vascular disease
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2023-08-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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 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.


Eligibility 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.

Primary outcomes:
measure: Median (range) hand acceleration time measured by Doppler ultrasound
timeFrame: Day 1
Secondary outcomes:
measure: Median (range) age of the participants.
timeFrame: Day 1
measure: Number (percentage) of male/female participants.
timeFrame: Day 1
measure: Number (percentage) of patients presenting cardiovascular risk factors of interest.
timeFrame: Day 1
measure: Number (percentage) of patients with past medical history of interest.
timeFrame: Day 1
measure: Presence (Yes/No) of distal pulses in the upper limb.
timeFrame: Day 1
Other outcomes:
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.