Peripheral Arterial Disease(AID-PAD)NCT06505317
Artificial Intelligence for Early Detection of Peripheral Artery Disease
A study testing AI-based PAD screening intervention in people with Peripheral Arterial Disease, run by University of California, San Diego.
Trial summary
The goal of this clinical trial is to test an AI-based screening tool that will help to identify patients at high risk of having undiagnosed peripheral artery disease. The primary outcome measure is overall rate of new PAD diagnoses. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- AI-based PAD screening intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,800 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 50-85 years
- Presenting to an outpatient appointment at UCSDH, SDVA, or SHC
- No previous diagnosis of PAD
- No prior PAD alert triggered for a previous visit
Who cannot join
- <50 years of age or > 85 years of age
- Prior diagnosis of PAD
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to test an AI-based screening tool that will help to identify patients at high risk of having undiagnosed peripheral artery disease. The primary outcome measure is overall rate of new PAD diagnoses. Secondary outcomes include rate of new secondary prevention measures initiated for PAD, which will include new prescriptions for antiplatelets, PAD-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level.
Read the detailed description
After providers consent to participate in this study, a screening tool will be deployed for their weekly clinics to identify patients at high risk of having undiagnosed PAD. These high risk alerts will be provided after a patient has checked in for their outpatient appointment. The alert will be sent to their treating provider once the visit is initiated in the electronic health record system (EHR). The primary outcome measure is overall rate of new PAD diagnoses. Secondary outcomes include rate of new secondary prevention measures initiated for PAD, which will include new prescriptions for antiplatelets, PAD-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level. For secondary analysis we will specifically evaluate patients who generated an alert and assess how patient demographics and/or clinical factors are associated with likelihood of ABI testing, rate of abnormal ABIs (i.e. true positive rate), and subsequent initiation of secondary prevention measures.
UC San Diego Health (UCSDH), VA San Diego Health Care (VASDHC), and Stanford Health Care (SHC) will be the sites for study enrollment. UCSDH - La Jolla campus, UCSDH - Hillcrest campus, and VASDHC will begin a pre-intervention observation period at the same time, and then each site will be randomized to begin screening tool intervention in a stepped wedge pattern at 13-week intervals for a total of 52 weeks. We will enroll 10 clinics per site based on power calculations for number of patients needed to screen each week and to minimize the number of alerts per clinic/ provider. After this 52 week period, the Stanford site will serve as a validation site and will undergo randomization of 10 clinical sites to three 13 week intervals for a total of 52 weeks.
- Conditions
- Peripheral Arterial Disease
- Being tested
- AI-based PAD screening intervention
- Keywords
- Peripheral Arterial Disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based PAD screening interventionDiagnostic test
Providers will receive alerts for a patient that is flagged by model as being "high risk" for PAD. This will allow the provider to review the alert, check the patient's previous history, develop additional questions to assess the risk of PAD, and initiate orders prior to seeing a patient. Depending on their assessment during the patient visit the provider may choose to order an ABI test (or perform one at bedside) and/or initiate other secondary prevention measures. All patients for which an alert is triggered will be included for secondary analysis.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Site 1 | Experimental | Randomized to start AI-based PAD screening interventionat week 13. Receives: Diagnostic Test: AI-based PAD screening intervention |
| Clinical Site 2 | Experimental | Randomized to start AI-based PAD screening intervention at Week 26. Receives: Diagnostic Test: AI-based PAD screening intervention |
| Clinical Site 3 | Experimental | Randomized to start AI-based PAD screening intervention at Week 39. Receives: Diagnostic Test: AI-based PAD screening intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAD Diagnosis Rate
The primary outcome will be counted at a clinic and site level and will include number of new abnormal ABI tests (ABI< 0.9), and new diagnosis codes, procedures or affirmative text mentions for PAD for patients without a previous diagnosis
Measured: During 13-39 weeks prior to intervention compared to 13-39 weeks during intervention depending on timing of randomization to intervention period.
Secondary outcomes (1)
Initiation of secondary prevention measures
New prescriptions for antiplatelets, PAD-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level time period.
Measured: During 13-39 weeks prior to intervention compared to 13-39 weeks during intervention depending on timing of randomization to intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A stepped wedge cluster randomization design was chosen as a pragmatic way to evaluate the "real world" impact of AI-based PAD screening. The stepped wedge design has been used to evaluate a variety of interventions, including digital health-based studies. This particular design allows for analysis within and between clusters and can reduce the total number of clusters needed to see an effect, helping increase statistical power compared to parallel cluster randomization. A stepped wedge design, like other cluster randomization designs, also helps reduce possible contamination effects. By using institutions as the basis for clustering, we minimize the possibility that physicians increase their PAD diagnosis rates based on knowledge of the screening tool from adjacent clinics rather than direct use.
- Masking
- None (open label)
- Enrolment
- 7,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Elsie Ross, University of California, San Diego
- Investigators
- Elsie Ross, MD, MSc, Principal investigator, UC San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505317
- Sponsor's protocol ID
- (AID-PAD)
- Other IDs
- R01AG084343-01
- Acronym
- (AID-PAD)
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2024
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ghanzouri I, Amal S, Ho V, Safarnejad L, Cabot J, Brown-Johnson CG, Leeper N, Asch S, Shah NH, Ross EG. Performance and usability testing of an automated tool for detection of peripheral artery disease using electronic health records. Sci Rep. 2022 Aug 3;12(1):13364. doi: 10.1038/s41598-022-17180-5.
PubMed 35922657
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence for Early Detection of Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT06505317
- Acronym / sponsor ID
- (AID-PAD) / (AID-PAD)
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 7,800 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Stanford University, National Institute on Aging (NIA)
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Jul 2024 (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.
The goal of this clinical trial is to test an AI-based screening tool that will help to identify patients at high risk of having undiagnosed peripheral artery disease. The primary outcome measure is overall rate of new PAD diagnoses. Secondary outcomes include rate of new secondary prevention measures initiated for PAD, which will include new prescriptions for antiplatelets, PAD-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level.
Detailed description
After providers consent to participate in this study, a screening tool will be deployed for their weekly clinics to identify patients at high risk of having undiagnosed PAD. These high risk alerts will be provided after a patient has checked in for their outpatient appointment. The alert will be sent to their treating provider once the visit is initiated in the electronic health record system (EHR). The primary outcome measure is overall rate of new PAD diagnoses. Secondary outcomes include rate of new secondary prevention measures initiated for PAD, which will include new prescriptions for antiplatelets, PAD-dosed rivaroxaban, statins, smoking cessation counseling or referrals, and/or supervised exercise therapy referrals also aggregated at a clinic and site level. For secondary analysis we will specifically evaluate patients who generated an alert and assess how patient demographics and/or clinical factors are associated with likelihood of ABI testing, rate of abnormal ABIs (i.e. true positive rate), and subsequent initiation of secondary prevention measures.
UC San Diego Health (UCSDH), VA San Diego Health Care (VASDHC), and Stanford Health Care (SHC) will be the sites for study enrollment. UCSDH - La Jolla campus, UCSDH - Hillcrest campus, and VASDHC will begin a pre-intervention observation period at the same time, and then each site will be randomized to begin screening tool intervention in a stepped wedge pattern at 13-week intervals for a total of 52 weeks. We will enroll 10 clinics per site based on power calculations for number of patients needed to screen each week and to minimize the number of alerts per clinic/ provider. After this 52 week period, the Stanford site will serve as a validation site and will undergo randomization of 10 clinical sites to three 13 week intervals for a total of 52 weeks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A stepped wedge cluster randomization design was chosen as a pragmatic way to evaluate the "real world" impact of AI-based PAD screening. The stepped wedge design has been used to evaluate a variety of interventions, including digital health-based studies. This particular design allows for analysis within and between clusters and can reduce the total number of clusters needed to see an effect, helping increase statistical power compared to parallel cluster randomization. A stepped wedge design, like other cluster randomization designs, also helps reduce possible contamination effects. By using institutions as the basis for clustering, we minimize the possibility that physicians increase their PAD diagnosis rates based on knowledge of the screening tool from adjacent clinics rather than direct use.
| Arm | Type | Receives |
|---|---|---|
| Clinical Site 1 | Experimental | Diagnostic Test: AI-based PAD screening interventionRandomized to start AI-based PAD screening interventionat week 13. |
| Clinical Site 2 | Experimental | Diagnostic Test: AI-based PAD screening interventionRandomized to start AI-based PAD screening intervention at Week 26. |
| Clinical Site 3 | Experimental | Diagnostic Test: AI-based PAD screening interventionRandomized to start AI-based PAD screening intervention at Week 39. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 50-85 years
- Presenting to an outpatient appointment at UCSDH, SDVA, or SHC
- No previous diagnosis of PAD
- No prior PAD alert triggered for a previous visit
Key exclusion criteria (2 listed)
- <50 years of age or > 85 years of age
- Prior diagnosis of PAD
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 |
|---|---|---|
| AI-based PAD screening interventionProviders will receive alerts for a patient that is flagged by model as being "high risk" for PAD. This will allow the provider to review the alert, check the patient's previous history, develop additional questions to assess the risk of PAD, and initiate orders prior to seeing a patient. Depending on their assessment during the patient visit the provider may choose to order an ABI test (or perform one at bedside) and/or initiate other secondary prevention measures. All patients for which an alert is triggered will be included for secondary analysis. | Diagnostic test | Clinical Site 1, Clinical Site 2, Clinical Site 3 |
Primary outcome
PAD Diagnosis Rate
Time frame: During 13-39 weeks prior to intervention compared to 13-39 weeks during intervention depending on timing of randomization to intervention period.
The primary outcome will be counted at a clinic and site level and will include number of new abnormal ABI tests (ABI< 0.9), and new diagnosis codes, procedures or affirmative text mentions for PAD for patients without a previous diagnosis
1 secondary outcome
Initiation of secondary prevention measures
Time frame: During 13-39 weeks prior to intervention compared to 13-39 weeks during intervention depending on timing of randomization to intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Background: PubMed 35922657Ghanzouri I, Amal S, Ho V, Safarnejad L, Cabot J, Brown-Johnson CG, Leeper N, Asch S, Shah NH, Ross EG. Performance and usability testing of an automated tool for detection of peripheral artery disease using electronic health records. Sci Rep. 2022 Aug 3;12(1):13364. doi: 10.1038/s41598-022-17180-5.
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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.
Elsie Ross, MD, MSc principal investigator
UC San Diego
Questions about this trial
What is this clinical trial studying?
A study testing AI-based PAD screening intervention in people with Peripheral Arterial Disease, run by University of California, San Diego.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Groh (8585348103, kagroh@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAD Diagnosis Rate (time frame: During 13-39 weeks prior to intervention compared to 13-39 weeks during intervention depending on timing of randomization to intervention period.). 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 NCT06505317, which also lists 1 linked publication.
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 17 Jul 2024.