Upper Limb IschemiaHATNCT05977725
Hand Acceleration Time Assessment With Ultrasound Doppler
An observational study of Upper Limb Ischemia and Vascular Disease, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Ischemia, Vascular Disease
- What is being tested?
- Hand Doppler Ultrasound
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Healthy adult volunteers (≥ 18 years of age).
- No evidence of upper limb arterial disease.
- Who sign the written informed consent.
- Adult patients (≥ 18 years of age) with a known diagnosis of chronic upper limb ischemia.
- Who sign the written informed consent.
Who cannot join
- 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).
- Patients unable (at the investigator discretion) to understand or comply with any study-related procedure.
- Patients who refuse to participate.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: 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.
Read more
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.
- Conditions
- Upper Limb Ischemia, Vascular Disease
- Being tested
- Hand Doppler Ultrasound
- Keywords
- Hand acceleration time, Upper limb ischemia, Vascular disease
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Doppler UltrasoundDiagnostic test
Hand Doppler Ultrasound to assess the Hand Acceleration Time (HAT)
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Lack of upper limb arterial disease. Receives: Diagnostic Test: Hand Doppler Ultrasound | |
| Patients with Chronic Upper Limb Ischemia | Known diagnosis of chronic upper limb ischemia. Receives: Diagnostic Test: Hand Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (5)
Median (range) age of the participants.
Measured: Day 1
Number (percentage) of male/female participants.
Measured: Day 1
Number (percentage) of patients presenting cardiovascular risk factors of interest.
Cardiovascular risk factors of interest are smoking habits, arterial hypertension, diabetes mellitus, and dyslipidemia).
Measured: Day 1
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.
Measured: Day 1
Presence (Yes/No) of distal pulses in the upper limb.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Jun 2023
- Primary completion30 Sep 2023
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Upper Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Begoña Gonzalo Villanueva, Hospital Universitari de Bellvitge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977725
- Sponsor's protocol ID
- 1 - VASC - 2023
- Acronym
- HAT
- Status last verified
- Jan 2024
- First submitted
- 28 Jul 2023
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 31075481Teso 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.
PubMed 33823258Strosberg 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.
PubMed 28390773Wang 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.
PubMed 34924370Takemoto 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.
PubMed 24345631Zarzecki 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.
PubMed 30245020Gonzalo 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.
PubMed 40839871
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Assessment of the Hand Arterial Perfusion Through the Ultrasound-Doppler Hand Acceleration Time (HAT) Technique: A Descriptive Study
- ClinicalTrials.gov ID
- NCT05977725
- Acronym / sponsor ID
- HAT / 1 - VASC - 2023
- Conditions
- Upper Limb Ischemia, Vascular Disease
- Keywords
- Hand acceleration time, Upper limb ischemia, Vascular disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Diagnostic Test: Hand Doppler UltrasoundLack of upper limb arterial disease. |
| Patients with Chronic Upper Limb Ischemia | – | Diagnostic Test: Hand Doppler UltrasoundKnown diagnosis of chronic upper limb ischemia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Healthy adult volunteers (≥ 18 years of age).
- No evidence of upper limb arterial disease.
- Who sign the written informed consent.
- Adult patients (≥ 18 years of age) with a known diagnosis of chronic upper limb ischemia.
- Who sign the written informed consent.
Key exclusion criteria (5 listed)
- 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).
- Patients unable (at the investigator discretion) to understand or comply with any study-related procedure.
- Patients who refuse to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand Doppler UltrasoundHand Doppler Ultrasound to assess the Hand Acceleration Time (HAT) | Diagnostic test | Healthy Volunteers, Patients with Chronic Upper Limb Ischemia |
Primary outcome
Median (range) hand acceleration time measured by Doppler ultrasound
Time frame: Day 1
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
5 secondary outcomes
Median (range) age of the participants.
Time frame: Day 1
Number (percentage) of male/female participants.
Time frame: Day 1
Number (percentage) of patients presenting cardiovascular risk factors of interest.
Time frame: Day 1
Number (percentage) of patients with past medical history of interest.
Time frame: Day 1
Presence (Yes/No) of distal pulses in the upper limb.
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 31075481Sommerset 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.
- Background: PubMed 33823258Teso 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.
- Background: PubMed 28390773Strosberg 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.
- Background: PubMed 34924370Wang 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.
- Background: PubMed 24345631Takemoto 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.
- Background: PubMed 30245020Zarzecki 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.
- Derived from this study: PubMed 40839871Gonzalo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Limb Ischemia and Vascular Disease, run by Hospital Universitari de Bellvitge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median (range) hand acceleration time measured by Doppler ultrasound (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05977725, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2024.