Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT)

NCT01419080 | Completed Results

• 1 other identifier: 11-533
• Study Type: observational
• Target: 797
• Locations: 1 country
• Sites: 10

Brief 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. 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.

Conditions

Peripheral Arterial Disease; Quality of Life; Quality of Care

Keywords

Peripheral Arterial Disease; Quality of Life; Quality of Care

Outcome Measures

Primary Outcomes (1)

• 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.

  One Year

Secondary Outcomes (1)

• All-cause Mortality

  One Year

Study Arms (1)

Peripheral Arterial Disease (PAD) patients

Patients with new onset or exacerbation of peripheral artery (PA) symptoms.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saint Luke's Health System: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (10)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, 48106, United States

Location

Truman Medical Center

Kansas City, Missouri, 64108, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Miriam Hospital

Providence, Rhode Island, 02904, United States

Location

Related Publications (11)

• 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.

  PMID: 17374814 BACKGROUND

• Smolderen 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.

  PMID: 37638882 DERIVED

• Angraal 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.

  PMID: 35579010 DERIVED

• Scierka 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.

  PMID: 34793986 DERIVED

• Jelani 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.

  PMID: 34506511 DERIVED

• Peri-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.

  PMID: 33947205 DERIVED

• Malik 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.

  PMID: 33279876 DERIVED

• Jelani 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.

  PMID: 32781883 DERIVED

• Jelani 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.

  PMID: 32539108 DERIVED

• Jelani 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.

  PMID: 31603393 DERIVED

• Smolderen 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.

  PMID: 29440123 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Results Point of Contact

• Title: John Spertus
• Organization: Saint Luke's Hospital of Kansas City

jspertus@saint-lukes.org

816-932-8270

Study Officials

• Kim Smolderen, PhD

  St. Luke's Hospital, Kansas City, Missouri

  PRINCIPAL INVESTIGATOR

• John A Spertus, MD, MPH

  St. Luke's Hospital, Kansas City, Missouri

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 17, 2011
• Study Start: October 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 24, 2025
• Results First Posted: July 17, 2019

Record last verified: 2025-10

Locations

US (10)