We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01419080
Recruitment Status : Active, not recruiting
First Posted : August 17, 2011
Results First Posted : July 17, 2019
Last Update Posted : May 4, 2022
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Saint Luke's Health System

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.

Condition or disease
Peripheral Arterial Disease Quality of Life Quality of Care

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 797 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT Registry)
Actual Study Start Date : October 2013
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Peripheral Arterial Disease (PAD) patients
Patients with new onset or exacerbation of peripheral artery (PA) symptoms.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. All-cause Mortality [ Time Frame: One Year ]
    all-cause mortality

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419080

Layout table for location information
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
Yale University
New Haven, Connecticut, United States, 06520
United States, Louisiana
Ochsner Health System
New Orleans, Louisiana, United States, 70121
United States, Michigan
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
United States, Missouri
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Miriam Hospital
Providence, Rhode Island, United States, 02904
Sponsors and Collaborators
Saint Luke's Health System
Patient-Centered Outcomes Research Institute
Layout table for investigator information
Principal Investigator: Kim Smolderen, PhD Saint Luke's Hospital of Kansas City
Principal Investigator: John A Spertus, MD, MPH Saint Luke's Hospital of Kansas City
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Saint Luke's Health System
ClinicalTrials.gov Identifier: NCT01419080    
Other Study ID Numbers: 11-533
First Posted: August 17, 2011    Key Record Dates
Results First Posted: July 17, 2019
Last Update Posted: May 4, 2022
Last Verified: April 2022
Keywords provided by Saint Luke's Health System:
Peripheral Arterial Disease
Quality of Life
Quality of Care
Additional relevant MeSH terms:
Layout table for MeSH terms
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases