Hand Acceleration Time Assessment With Ultrasound Doppler

Vascular Disease Clinical Trial

— HAT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05977725
• Other study ID #: 1 - VASC - 2023
• Status: Active, not recruiting
• Start date: June 1, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2024
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: April 30, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Vascular Disease
• Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Universitari de Bellvitge	L'Hospitalet De Llobregat	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari de Bellvitge

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median (range) hand acceleration time measured by Doppler ultrasound	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	Median (range) age of the participants.		Day 1
Secondary	Number (percentage) of male/female participants.		Day 1
Secondary	Number (percentage) of patients presenting cardiovascular risk factors of interest.	Cardiovascular risk factors of interest are smoking habits, arterial hypertension, diabetes mellitus, and dyslipidemia).	Day 1
Secondary	Number (percentage) of patients with past medical history of interest.	A past medical history of interest is defined as ischemic cardiopathy, heart failure, and chronic obstructive pulmonary disease.	Day 1
Secondary	Presence (Yes/No) of distal pulses in the upper limb.		Day 1