Trial Outcomes & Findings for Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT) (NCT NCT01419080)

NCT ID: NCT01419080

Last Updated: 2025-10-24

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

797 participants

Primary outcome timeframe

One Year

Results posted on

2025-10-24

Participant Flow

Participant milestones

Participant milestones
Measure	Peripheral Arterial Disease (PAD) Patients Patients with new onset or exacerbation of peripheral artery (PA) symptoms.
Overall Study STARTED	797
Overall Study COMPLETED	666
Overall Study NOT COMPLETED	131

Reasons for withdrawal

Reasons for withdrawal
Measure	Peripheral Arterial Disease (PAD) Patients Patients with new onset or exacerbation of peripheral artery (PA) symptoms.
Overall Study Withdrawal by Subject	75
Overall Study Death	30
Overall Study Lost to Follow-up	23
Overall Study Too Ill	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peripheral Arterial Disease (PAD) Patients n=797 Participants Patients with new onset or exacerbation of peripheral artery (PA) symptoms.
Age, Continuous	68.6 years STANDARD_DEVIATION 9.7 • n=39 Participants
Sex: Female, Male Female	334 Participants n=39 Participants
Sex: Female, Male Male	463 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	782 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race/Ethnicity, Customized Race · White	577 Participants n=39 Participants
Race/Ethnicity, Customized Race · Black	183 Participants n=39 Participants
Race/Ethnicity, Customized Race · Other	37 Participants n=39 Participants
Region of Enrollment United States	797 participants n=39 Participants
Peripheral Artery Questionnaire Summary Score Baseline	46.8 units on a scale (0-100) STANDARD_DEVIATION 22 • n=39 Participants

PRIMARY outcome

Timeframe: One Year

Outcome measures

Outcome measures
Measure	Received Invasive Treatment n=141 Participants Received invasive treatment (endovascular, surgical) as a primary treatment strategy (\<=3 months following enrollment)	Did Not Receive Invasive Treatment n=552 Participants Did not receive invasive treatment (endovascular, surgical) as a primary treatment strategy (\<=3 months following enrollment)
Peripheral Artery Disease (PAD) - Specific Health Status	70.7 units on a scale of 0-100 Standard Deviation 25.4	66.9 units on a scale of 0-100 Standard Deviation 25.1

SECONDARY outcome

Timeframe: One Year

all-cause mortality

Outcome measures

Outcome measures
Measure	Received Invasive Treatment n=797 Participants Received invasive treatment (endovascular, surgical) as a primary treatment strategy (\<=3 months following enrollment)	Did Not Receive Invasive Treatment Did not receive invasive treatment (endovascular, surgical) as a primary treatment strategy (\<=3 months following enrollment)
All-cause Mortality	30 Participants	—

Adverse Events

Peripheral Arterial Disease (PAD) Patients

Serious events: 30 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Peripheral Arterial Disease (PAD) Patients n=797 participants at risk Patients with new onset or exacerbation of peripheral artery (PA) symptoms.
General disorders All cause mortality	3.8% 30/797 • Number of events 30

Other adverse events

Adverse event data not reported

Additional Information

John Spertus

Saint Luke's Hospital of Kansas City

Phone: 816-932-8270

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place