Peripheral Arterial DiseasePORTRAITNCT01419080
Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT)
An observational study of Peripheral Arterial Disease and Quality of Life, run by Saint Luke's Health System at 10 sites in United States.
Trial summary
An estimated 8 million individuals in America are affected by peripheral arterial disease (PAD), blockages of the leg arteries that can cause excruciating calf pain when walking. PAD can have a tremendous impact on patients' quality of life. It is also associated with high rates of heart attacks and premature death. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Quality of Life, Quality of Care
- How many people
- 797 participants
- Where
- 10 sitesUnited States
- Study dates
- Oct 2013to Dec 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to a PAD specialty clinic with new-onset exertional leg symptoms, or recent exacerbations of symptoms, will be screened for enrollment at 10 specialty PAD clinics. Trained study coordinators will have access to the outpatient clinic's schedule and be able to identify potentially eligible patients a priori so as to review medical records and identify potential patients. The diagnostic enrollment criterion includes a Doppler resting ankle-brachial index (ABI) ≤0.9026 or a significant drop in post-exercise ankle pressure of ≥20 mmHg. Patients will be asked to participate upon first visiting the PAD clinic, before treatment is started. Study coordinators at each center will obtain informed consent and perform the baseline interview at the outpatient clinic.
Who may be able to join
- Age ≥ 21 years
- New or recent exacerbation of exertional leg symptoms
- Resting ankle-brachial index assessment ≤0.90 or drop in post-exercise ankle pressure ≥20 mmHg
Who cannot join
- Non-compressible ankle-brachial index (≥1.30)
- Critical limb ischemia
- Lower-limb endovascular or surgical vascular procedure in past year
- Not speaking either English or Spanish
- Hearing impaired
- Unable to provide written informed consent
- Currently a prisoner
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106
Bridgeport Hospital
Bridgeport, Connecticut, 06610
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University Medical Center
Durham, North Carolina, 27710
Truman Medical Center
Kansas City, Missouri, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Yale University
New Haven, Connecticut, 06520
Ochsner Health System
New Orleans, Louisiana, 70121
Rhode Island Hospital
Providence, Rhode Island, 02903
Miriam Hospital
Providence, Rhode Island, 02904
About this study
Official title: Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT Registry)
An estimated 8 million individuals in America are affected by peripheral arterial disease (PAD), blockages of the leg arteries that can cause excruciating calf pain when walking. PAD can have a tremendous impact on patients' quality of life. It is also associated with high rates of heart attacks and premature death. While there are a number of treatments, there have been few previous studies that have prospectively examined treatment patterns for PAD or sought to systematically identify opportunities to improve care. Most importantly, there have been no rigorous studies examining the impact of the disease from patients' perspectives - their symptoms, function and quality of life - as a function of different patient characteristics and treatments. The PORTRAIT study (Phase II) will systematically document the treatments and health status (symptom, function and quality of life) outcomes of 840 US patients over the course of one year (assessments at baseline, 3, 6, and 12 months) from 10 centers to address these gaps in knowledge. It will illuminate whether disparities in treatment or health status outcomes exist as a function of patients' age, gender, race, socioeconomic or psychological characteristics. PORTRAIT will substantially elevate the field and identify critical gaps in the way PAD is currently managed, including potential disparities in care, so that the quality of care can be improved.
Read the detailed description
Peripheral arterial disease (PAD) is a highly prevalent, but undertreated atherosclerotic disease with a disproportionately poor cardiovascular prognosis, as compared with other cardiovascular diseases. Cardiac events are, however, only one manifestation of PAD. Patients' health status (symptoms, function, and quality of life) are critical outcomes from patients' perspectives. To date, there have been no systematic prospective evaluations of disease-specific health status outcomes in PAD and how these vary by treatment and patient characteristics. The long-term goal of our work is to create an evidence-based multi-modal PAD management program that can be individualized to each patient. Following our preparatory work in Pilot PCORI grant 1 IP2 PI000753-01, the current proposal will develop a multi-center observational registry called PORTRAIT (Patient-centered Outcomes Related to Treatment Practices in peripheral Arterial disease: Investigating Trajectories). PORTRAIT will prospectively define and relate patients' care to their health status outcomes as a function of their treatment received at specialty clinics for new-onset, or exacerbations, of their PAD. We hypothesize that there will be substantial variability in treatment patterns across providers and by patient characteristics and that these will explain much of the variation in patients' health status outcomes. Four hypothesis-driven specific aims will be tested; the 5th aim will result in a direct deliverable from this study:
Aim 1: We hypothesize strong associations between the severity of patients' health status and the use of revascularization and that these will vary by age, gender, race, and socio-economic status. This aim will examine variations in treatment by patient characteristics as a foundation for identifying disparities in care.
Aim 2: We hypothesize that revascularization will be associated with more rapid, and larger, improvements in health status as compared with non-invasive options, and that these benefits will vary by age, gender, baseline health status, smoking cessation, minority race, and depressive symptoms. The primary objective of PORTRAIT is to quantify patients' PAD-specific health status outcomes overall, and as a function of treatment and patient characteristics.
Aim 3: We hypothesize that variations in performance measure adherence exist across providers, with greater adherence to pharmacologic therapies for prevention, than exercise treatments to improve function. We will compare real world PAD care against 4 PAD performance measures to provide insights into the quality of PAD care.
Aim 4: We hypothesize that variations in pharmacologic and supervised exercise will be associated with differences in health status outcomes and provide the evidence to suggest that failure to prescribe these evidence-based treatments will result in lower health status scores.
Aim 5: Use the new information to create educational tools to assist patients in selecting treatments.
- Keywords
- Peripheral Arterial Disease, Quality of Life, Quality of Care
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Arterial Disease (PAD) patients | Patients with new onset or exacerbation of peripheral artery (PA) symptoms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Artery Disease (PAD) - Specific Health Status
Scores on a scale of 0-100 with higher scores representing better health status (0= worst health imaginable, 100= best health imaginable). Subscales are weighed in a standardized scoring algorithm (proprietary). Measures symptoms, symptom stability, and quality of life.
Measured: One Year
Secondary outcomes (1)
All-cause Mortality
all-cause mortality
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2011 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 797 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saint Luke's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Kim Smolderen, PhD, Principal investigator, St. Luke's Hospital, Kansas City, MissouriJohn A Spertus, MD, MPH, Principal investigator, St. Luke's Hospital, Kansas City, Missouri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419080
- Sponsor's protocol ID
- 11-533
- Acronym
- PORTRAIT
- Status last verified
- Oct 2025
- First submitted
- 16 Aug 2011
- Last updated
- 24 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Steg PG, Bhatt DL, Wilson PW, D'Agostino R Sr, Ohman EM, Rother J, Liau CS, Hirsch AT, Mas JL, Ikeda Y, Pencina MJ, Goto S; REACH Registry Investigators. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA. 2007 Mar 21;297(11):1197-206. doi: 10.1001/jama.297.11.1197.
PubMed 17374814Scierka LE, Peri-Okonny PA, Romain G, Cleman J, Spertus JA, Fitridge R, Secemsky E, Patel MR, Gosch KL, Mena-Hurtado C, Smolderen KG. Psychosocial and socioeconomic factors are most predictive of health status in patients with claudication. J Vasc Surg. 2024 Jun;79(6):1473-1482.e5. doi: 10.1016/j.jvs.2024.01.021. Epub 2024 Jan 22.
PubMed 38266885Smolderen KG, Romain G, Gosch K, Arham A, Provance JB, Spertus JA, Poosala AB, Shishehbor MH, Safley D, Scott K, Stone N, Mena-Hurtado C. Patient knowledge and preferences for peripheral artery disease treatment. Vasc Med. 2023 Oct;28(5):397-403. doi: 10.1177/1358863X231181613. Epub 2023 Aug 28.
PubMed 37638882Angraal S, Hejjaji V, Tang Y, Gosch KL, Patel MR, Heyligers J, White CJ, Tutein Nolthenius R, Mena-Hurtado C, Aronow HD, Moneta GL, Fitridge R, Soukas PA, Abbott JD, Secemsky EA, Spertus JA, Smolderen KG. One-Year Health Status Outcomes Following Early Invasive and Noninvasive Treatment in Symptomatic Peripheral Artery Disease. Circ Cardiovasc Interv. 2022 Jun;15(6):e011506. doi: 10.1161/CIRCINTERVENTIONS.121.011506. Epub 2022 May 17.
PubMed 35579010Scierka LE, Jelani QU, Smolderen KG, Gosch K, Spertus JA, Mena-Hurtado C, Jones P, Dreyer RP. Patient representativeness of a peripheral artery disease cohort in a randomized control trial versus a real-world cohort: The CLEVER trial versus the PORTRAIT registry. Contemp Clin Trials. 2022 Jan;112:106624. doi: 10.1016/j.cct.2021.106624. Epub 2021 Nov 16.
PubMed 34793986Jelani QU, Mena-Hurtado C, Gosch K, Mohammed M, Labrosciano C, Regan C, Scierka LE, Spertus JA, Nagpal S, Smolderen KG. Association of sleep apnea with outcomes in peripheral artery disease: Insights from the PORTRAIT study. PLoS One. 2021 Sep 10;16(9):e0256933. doi: 10.1371/journal.pone.0256933. eCollection 2021.
PubMed 34506511Peri-Okonny PA, Wang J, Gosch KL, Patel MR, Shishehbor MH, Safley DL, Abbott JD, Aronow HD, Mena-Hurtado C, Jelani QU, Tang Y, Bunte M, Labrosciano C, Beltrame JF, Spertus JA, Smolderen KG. Establishing Thresholds for Minimal Clinically Important Differences for the Peripheral Artery Disease Questionnaire. Circ Cardiovasc Qual Outcomes. 2021 May;14(5):e007232. doi: 10.1161/CIRCOUTCOMES.120.007232. Epub 2021 May 5.
PubMed 33947205Malik AO, Poghni Peri-Okonny, Gosch K, Thomas MB, Mena-Hurtado C, Hiatt W, Aronow HD, Jones PG, Provance J, Labrosciano C, Jelani QU, Spertus JA, Smolderen KG. Association of perceived stress with health status outcomes in patients with peripheral artery disease. J Psychosom Res. 2021 Jan;140:110313. doi: 10.1016/j.jpsychores.2020.110313. Epub 2020 Nov 24.
PubMed 33279876Jelani QU, Mena-Hurtado C, Burg M, Soufer R, Gosch K, Jones PG, Spertus JA, Safdar B, Smolderen KG. Relationship Between Depressive Symptoms and Health Status in Peripheral Artery Disease: Role of Sex Differences. J Am Heart Assoc. 2020 Aug 18;9(16):e014583. doi: 10.1161/JAHA.119.014583. Epub 2020 Aug 12.
PubMed 32781883Jelani QU, Smolderen KG, Halpin D, Gosch K, Spertus JA, Iyad Ochoa Chaar C, Tutein Nolthenius RP, Heyligers J, De Vries JP, Mena-Hurtado C. Patient profiles and health status outcomes for peripheral artery disease in high-income countries: a comparison between the USA and The Netherlands. Eur Heart J Qual Care Clin Outcomes. 2021 Sep 16;7(5):505-512. doi: 10.1093/ehjqcco/qcaa052.
PubMed 32539108Jelani QU, Jhamnani S, Spatz ES, Spertus J, Smolderen KG, Wang J, Desai NR, Jones P, Gosch K, Shah S, Attaran R, Mena-Hurtado C. Financial barriers in accessing medical care for peripheral artery disease are associated with delay of presentation and adverse health status outcomes in the United States. Vasc Med. 2020 Feb;25(1):13-24. doi: 10.1177/1358863X19872542. Epub 2019 Oct 11.
PubMed 31603393Smolderen KG, Gosch K, Patel M, Jones WS, Hirsch AT, Beltrame J, Fitridge R, Shishehbor MH, Denollet J, Vriens P, Heyligers J, Stone MEd N, Aronow H, Abbott JD, Labrosciano C, Tutein-Nolthenius R, A Spertus J. PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories): Overview of Design and Rationale of an International Prospective Peripheral Arterial Disease Study. Circ Cardiovasc Qual Outcomes. 2018 Feb;11(2):e003860. doi: 10.1161/CIRCOUTCOMES.117.003860.
PubMed 29440123
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT Registry)
- ClinicalTrials.gov ID
- NCT01419080
- Acronym / sponsor ID
- PORTRAIT / 11-533
- Keywords
- Peripheral Arterial Disease, Quality of Life, Quality of Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 797 participants (actual)
- Lead sponsor
- Saint Luke's Health SystemUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Oct 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Aug 2011 (estimated)
- Results
- Posted 17 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An estimated 8 million individuals in America are affected by peripheral arterial disease (PAD), blockages of the leg arteries that can cause excruciating calf pain when walking. PAD can have a tremendous impact on patients' quality of life. It is also associated with high rates of heart attacks and premature death. While there are a number of treatments, there have been few previous studies that have prospectively examined treatment patterns for PAD or sought to systematically identify opportunities to improve care. Most importantly, there have been no rigorous studies examining the impact of the disease from patients' perspectives - their symptoms, function and quality of life - as a function of different patient characteristics and treatments. The PORTRAIT study (Phase II) will systematically document the treatments and health status (symptom, function and quality of life) outcomes of 840 US patients over the course of one year (assessments at baseline, 3, 6, and 12 months) from 10 centers to address these gaps in knowledge. It will illuminate whether disparities in treatment or health status outcomes exist as a function of patients' age, gender, race, socioeconomic or psychological characteristics. PORTRAIT will substantially elevate the field and identify critical gaps in the way PAD is currently managed, including potential disparities in care, so that the quality of care can be improved.
Detailed description
Peripheral arterial disease (PAD) is a highly prevalent, but undertreated atherosclerotic disease with a disproportionately poor cardiovascular prognosis, as compared with other cardiovascular diseases. Cardiac events are, however, only one manifestation of PAD. Patients' health status (symptoms, function, and quality of life) are critical outcomes from patients' perspectives. To date, there have been no systematic prospective evaluations of disease-specific health status outcomes in PAD and how these vary by treatment and patient characteristics. The long-term goal of our work is to create an evidence-based multi-modal PAD management program that can be individualized to each patient. Following our preparatory work in Pilot PCORI grant 1 IP2 PI000753-01, the current proposal will develop a multi-center observational registry called PORTRAIT (Patient-centered Outcomes Related to Treatment Practices in peripheral Arterial disease: Investigating Trajectories). PORTRAIT will prospectively define and relate patients' care to their health status outcomes as a function of their treatment received at specialty clinics for new-onset, or exacerbations, of their PAD. We hypothesize that there will be substantial variability in treatment patterns across providers and by patient characteristics and that these will explain much of the variation in patients' health status outcomes. Four hypothesis-driven specific aims will be tested; the 5th aim will result in a direct deliverable from this study:
Aim 1: We hypothesize strong associations between the severity of patients' health status and the use of revascularization and that these will vary by age, gender, race, and socio-economic status. This aim will examine variations in treatment by patient characteristics as a foundation for identifying disparities in care.
Aim 2: We hypothesize that revascularization will be associated with more rapid, and larger, improvements in health status as compared with non-invasive options, and that these benefits will vary by age, gender, baseline health status, smoking cessation, minority race, and depressive symptoms. The primary objective of PORTRAIT is to quantify patients' PAD-specific health status outcomes overall, and as a function of treatment and patient characteristics.
Aim 3: We hypothesize that variations in performance measure adherence exist across providers, with greater adherence to pharmacologic therapies for prevention, than exercise treatments to improve function. We will compare real world PAD care against 4 PAD performance measures to provide insights into the quality of PAD care.
Aim 4: We hypothesize that variations in pharmacologic and supervised exercise will be associated with differences in health status outcomes and provide the evidence to suggest that failure to prescribe these evidence-based treatments will result in lower health status scores.
Aim 5: Use the new information to create educational tools to assist patients in selecting treatments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral Arterial Disease (PAD) patients | – | –Patients with new onset or exacerbation of peripheral artery (PA) symptoms. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to a PAD specialty clinic with new-onset exertional leg symptoms, or recent exacerbations of symptoms, will be screened for enrollment at 10 specialty PAD clinics. Trained study coordinators will have access to the outpatient clinic's schedule and be able to identify potentially eligible patients a priori so as to review medical records and identify potential patients. The diagnostic enrollment criterion includes a Doppler resting ankle-brachial index (ABI) ≤0.9026 or a significant drop in post-exercise ankle pressure of ≥20 mmHg. Patients will be asked to participate upon first visiting the PAD clinic, before treatment is started. Study coordinators at each center will obtain informed consent and perform the baseline interview at the outpatient clinic.
Key inclusion criteria (3 listed)
- Age ≥ 21 years
- New or recent exacerbation of exertional leg symptoms
- Resting ankle-brachial index assessment ≤0.90 or drop in post-exercise ankle pressure ≥20 mmHg
Key exclusion criteria (7 listed)
- Non-compressible ankle-brachial index (≥1.30)
- Critical limb ischemia
- Lower-limb endovascular or surgical vascular procedure in past year
- Not speaking either English or Spanish
- Hearing impaired
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripheral Artery Disease (PAD) - Specific Health Status
Time frame: One Year
Scores on a scale of 0-100 with higher scores representing better health status (0= worst health imaginable, 100= best health imaginable). Subscales are weighed in a standardized scoring algorithm (proprietary). Measures symptoms, symptom stability, and quality of life.
1 secondary outcome
All-cause Mortality
Time frame: One Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17374814Steg PG, Bhatt DL, Wilson PW, D'Agostino R Sr, Ohman EM, Rother J, Liau CS, Hirsch AT, Mas JL, Ikeda Y, Pencina MJ, Goto S; REACH Registry Investigators. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA. 2007 Mar 21;297(11):1197-206. doi: 10.1001/jama.297.11.1197.
- Derived from this study: PubMed 38266885Scierka LE, Peri-Okonny PA, Romain G, Cleman J, Spertus JA, Fitridge R, Secemsky E, Patel MR, Gosch KL, Mena-Hurtado C, Smolderen KG. Psychosocial and socioeconomic factors are most predictive of health status in patients with claudication. J Vasc Surg. 2024 Jun;79(6):1473-1482.e5. doi: 10.1016/j.jvs.2024.01.021. Epub 2024 Jan 22.
- Derived from this study: PubMed 37638882Smolderen KG, Romain G, Gosch K, Arham A, Provance JB, Spertus JA, Poosala AB, Shishehbor MH, Safley D, Scott K, Stone N, Mena-Hurtado C. Patient knowledge and preferences for peripheral artery disease treatment. Vasc Med. 2023 Oct;28(5):397-403. doi: 10.1177/1358863X231181613. Epub 2023 Aug 28.
- Derived from this study: PubMed 35579010Angraal S, Hejjaji V, Tang Y, Gosch KL, Patel MR, Heyligers J, White CJ, Tutein Nolthenius R, Mena-Hurtado C, Aronow HD, Moneta GL, Fitridge R, Soukas PA, Abbott JD, Secemsky EA, Spertus JA, Smolderen KG. One-Year Health Status Outcomes Following Early Invasive and Noninvasive Treatment in Symptomatic Peripheral Artery Disease. Circ Cardiovasc Interv. 2022 Jun;15(6):e011506. doi: 10.1161/CIRCINTERVENTIONS.121.011506. Epub 2022 May 17.
- Derived from this study: PubMed 34793986Scierka LE, Jelani QU, Smolderen KG, Gosch K, Spertus JA, Mena-Hurtado C, Jones P, Dreyer RP. Patient representativeness of a peripheral artery disease cohort in a randomized control trial versus a real-world cohort: The CLEVER trial versus the PORTRAIT registry. Contemp Clin Trials. 2022 Jan;112:106624. doi: 10.1016/j.cct.2021.106624. Epub 2021 Nov 16.
- Derived from this study: PubMed 34506511Jelani QU, Mena-Hurtado C, Gosch K, Mohammed M, Labrosciano C, Regan C, Scierka LE, Spertus JA, Nagpal S, Smolderen KG. Association of sleep apnea with outcomes in peripheral artery disease: Insights from the PORTRAIT study. PLoS One. 2021 Sep 10;16(9):e0256933. doi: 10.1371/journal.pone.0256933. eCollection 2021.
- Derived from this study: PubMed 33947205Peri-Okonny PA, Wang J, Gosch KL, Patel MR, Shishehbor MH, Safley DL, Abbott JD, Aronow HD, Mena-Hurtado C, Jelani QU, Tang Y, Bunte M, Labrosciano C, Beltrame JF, Spertus JA, Smolderen KG. Establishing Thresholds for Minimal Clinically Important Differences for the Peripheral Artery Disease Questionnaire. Circ Cardiovasc Qual Outcomes. 2021 May;14(5):e007232. doi: 10.1161/CIRCOUTCOMES.120.007232. Epub 2021 May 5.
- Derived from this study: PubMed 33279876Malik AO, Poghni Peri-Okonny, Gosch K, Thomas MB, Mena-Hurtado C, Hiatt W, Aronow HD, Jones PG, Provance J, Labrosciano C, Jelani QU, Spertus JA, Smolderen KG. Association of perceived stress with health status outcomes in patients with peripheral artery disease. J Psychosom Res. 2021 Jan;140:110313. doi: 10.1016/j.jpsychores.2020.110313. Epub 2020 Nov 24.
- Derived from this study: PubMed 32781883Jelani QU, Mena-Hurtado C, Burg M, Soufer R, Gosch K, Jones PG, Spertus JA, Safdar B, Smolderen KG. Relationship Between Depressive Symptoms and Health Status in Peripheral Artery Disease: Role of Sex Differences. J Am Heart Assoc. 2020 Aug 18;9(16):e014583. doi: 10.1161/JAHA.119.014583. Epub 2020 Aug 12.
- Derived from this study: PubMed 32539108Jelani QU, Smolderen KG, Halpin D, Gosch K, Spertus JA, Iyad Ochoa Chaar C, Tutein Nolthenius RP, Heyligers J, De Vries JP, Mena-Hurtado C. Patient profiles and health status outcomes for peripheral artery disease in high-income countries: a comparison between the USA and The Netherlands. Eur Heart J Qual Care Clin Outcomes. 2021 Sep 16;7(5):505-512. doi: 10.1093/ehjqcco/qcaa052.
- Derived from this study: PubMed 31603393Jelani QU, Jhamnani S, Spatz ES, Spertus J, Smolderen KG, Wang J, Desai NR, Jones P, Gosch K, Shah S, Attaran R, Mena-Hurtado C. Financial barriers in accessing medical care for peripheral artery disease are associated with delay of presentation and adverse health status outcomes in the United States. Vasc Med. 2020 Feb;25(1):13-24. doi: 10.1177/1358863X19872542. Epub 2019 Oct 11.
- Derived from this study: PubMed 29440123Smolderen KG, Gosch K, Patel M, Jones WS, Hirsch AT, Beltrame J, Fitridge R, Shishehbor MH, Denollet J, Vriens P, Heyligers J, Stone MEd N, Aronow H, Abbott JD, Labrosciano C, Tutein-Nolthenius R, A Spertus J. PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories): Overview of Design and Rationale of an International Prospective Peripheral Arterial Disease Study. Circ Cardiovasc Qual Outcomes. 2018 Feb;11(2):e003860. doi: 10.1161/CIRCOUTCOMES.117.003860.
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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.
Kim Smolderen, PhD principal investigator
St. Luke's Hospital, Kansas City, Missouri
John A Spertus, MD, MPH principal investigator
St. Luke's Hospital, Kansas City, Missouri
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease and Quality of Life, run by Saint Luke's Health System at 10 sites in United States.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Peripheral Artery Disease (PAD) - Specific Health Status (time frame: One Year). 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 NCT01419080, which also lists 12 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 24 Oct 2025.