NCT05977725

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
Last Updated

January 11, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

July 28, 2023

Last Update Submit

January 10, 2024

Conditions

Keywords

Hand acceleration timeUpper limb ischemiaVascular disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Median (range) age of the participants.

    Day 1

  • Number (percentage) of male/female participants.

    Day 1

  • Number (percentage) of patients presenting cardiovascular risk factors of interest.

    Day 1

  • Number (percentage) of patients with past medical history of interest.

    Day 1

  • Presence (Yes/No) of distal pulses in the upper limb.

    Day 1

Study Arms (2)

Healthy Volunteers

Lack of upper limb arterial disease.

Diagnostic Test: Hand Doppler Ultrasound

Patients with Chronic Upper Limb Ischemia

Known diagnosis of chronic upper limb ischemia.

Diagnostic Test: Hand Doppler Ultrasound

Interventions

Hand Doppler Ultrasound to assess the Hand Acceleration Time (HAT)

Healthy VolunteersPatients with Chronic Upper Limb Ischemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Healthy adult volunteers (≥ 18 years of age).
  • No evidence of upper limb arterial disease.
  • Who sign the written informed consent.

You may not qualify if:

  • 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).
  • Adult patients (≥ 18 years of age) with a known diagnosis of chronic upper limb ischemia.
  • Who sign the written informed consent.
  • Patients unable (at the investigator discretion) to understand or comply with any study-related procedure.
  • Patients who refuse to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Related Publications (7)

  • 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.

    PMID: 31075481BACKGROUND
  • 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.

    PMID: 33823258BACKGROUND
  • 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.

    PMID: 28390773BACKGROUND
  • 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.

    PMID: 34924370BACKGROUND
  • 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.

    PMID: 24345631BACKGROUND
  • 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.

    PMID: 30245020BACKGROUND
  • Gonzalo B, Videla S, Moranas J, Carnaval T, Herranz C, Espinar E, Iborra E. Hemodynamic Assessment of Arterial Perfusion by Using the Ultrasonographic Hand Acceleration Time: Protocol for a Cross-Sectional Prospective Descriptive Study. JMIR Res Protoc. 2025 Aug 21;14:e64450. doi: 10.2196/64450.

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Expert Vascular Surgeon

Study Record Dates

First Submitted

July 28, 2023

First Posted

August 4, 2023

Study Start

June 1, 2023

Primary Completion

September 30, 2023

Study Completion

April 30, 2024

Last Updated

January 11, 2024

Record last verified: 2024-01

Locations