Prospective Case-control Study in Patients With PAA

A Prospective Case-control Study of the Quality of Life in Patients With Aneurysmatic or Occlusive Disease in the Lower Limb

The overall objective is to highlight different aspects of care in patients with PAA before and after treatment, and identifying factors that influence the outcome of PAA patients.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Peripheral Arterial Disease; Popliteal Artery Aneurysm
• Intervention / Treatment: Other: Bypass surgery

Detailed Description

An aneurysm is most commonly defined as a permanent focal dilatation of an artery to 1.5 times its normal diameter. While the abdominal aorta is the most common site of aneurysm formation, the popliteal artery (PA) represents the second most common site of aneurysm formation, accounting for more than 70 percent of all peripheral aneurysms. A popliteal artery aneurysm (PAA) is a focal dilatation of the popliteal artery (red arrow). PAAs are rare in the general population but more commonly found in patient populations with other aneurysms, such as abdominal aortic aneurysm (AAA). Within the general population, PAAs are predominantly found in men and are extremely rare in women. There are few studies on the prevalence of PAAs in healthy individuals, but 14-19% of male and 12% of female AAA patients have PAAs. There is no clear correlation between the diameter of the AAA and the prevalence of PAA. There is furthermore a lack of consensus of the precise arterial diameter that defines a PAA.

It is paramount to identify and treat PAA patients before acute symptoms develop, given the high risk of major complications associated with acute presentation, such as major amputation. Unfortunately, there is a lack of knowledge of the natural history for PAAs, which is why surgical procedures are recommended mainly based on clinical experience and guidelines developed from insufficient scientific information. The preventive purpose, more specifically to prevent the risk of acute symptom development, should be evaluated against the frequency of complications inflicted by surgical treatment, so called "surgical risk". For this reason, it is important to evaluate the patients' health-related quality of life (HRQoL) before and after treatment in order to determine how the surgical treatment affect patients. In general, the Health-Related Quality of Life (HRQoL) is therefore emerging as an important outcome measure for interventions designed to improve patient's health, well-being, or both. There is very limited prior knowledge of HRQoL outcomes following surgical treatment of PAAs and the PAA patient's HRQoL, and whether-and to what extent- it becomes affected by the surgical treatment, is yet unknown. The surgical treatment in PAA patients and patients with peripheral arterial disease (PAD), are comparable whereas the underlying pathologies are distinct. Thus, peripheral arterial disease patients commonly experience substantial symptom relief following a surgical intervention (i.e. lower limb pain is alleviated, or ischemic wound healing is promoted). By contrast, PAA patients are often asymptomatic prior to surgery. It is therefore conceivable that a surgical intervention in PAA patients translates to a lower HRQoL after surgery than what is observed following bypass surgery for PAD. However, this needs to be further explored and confirmed in prospective studies.

Aim To investigate whether the QoL of PAA patients compared to PAD patients after surgical and potential changes over time.

Hypothesis Compared to PAD patients, femoropopliteal/femorodistal bypass surgery interventions undertaken on PAA patients result in a more pronounced negative HRQoL impact.

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecka Hultgren, Prof; Phone Number: +46851776596; Email: rebecka.hultgren@ki.se
• Study Contact Backup: Name: Iva Jergovic, MD; Phone Number: +46851770947; Email: iva.jergovic@sll.se

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Joakim Nordanstig, MD, assoc prof.
  • Stockholm, Sweden
    • Recruiting
    • Karolinska University Hospital
    • Contact: Iva Jergovic, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients scheduled for elective surgery of PAA (asymptomatic)
• All patients scheduled for elective surgery of PAD
• Elective open surgery
• Intermittent claudication
• Resting pain or very limited minor tissue loss

Exclusion Criteria:

• Cognitive failure
• Major tissue loss
• severe pain
• if one cannot assimilate information in Swedish and understand the questionnaires

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Popliteal artery aneurysm; Asymptomatic popliteal artery aneurysm patients will undergo surgery with a femoropopliteal/femorodistal bypass	Other: Bypass surgery; All patients scheduled for elective surgery of PAA and PAD.
Active Comparator: Peripheral artery disease; Patients with peripheral artery disease defined as (ankle - brachial index, ABI <0.5 or typical symptoms); intermittent claudication (IC), or resting pain and/or minor tissue loss. Will undergo surgery with a femoropopliteal/femorodistal bypass	Other: Bypass surgery; All patients scheduled for elective surgery of PAA and PAD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SF-36	A 36-item questionnaire that measures 8 dimensions of physical and mental health. ( 0-100) Positive if high	Five years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EQ-5D	EQ-5D is a standardized instrument for measuring generic health status (0-100) 100 best Health and 0 worst helath	Five years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-9 PHQ-9	Depressive symptoms were assessed with the validated nine-item. Patient Health Questionnaire. The PHQ provides a dichotomous measure of depressive symptoms ( 0- 30; below 4 = no deression; 10 or above = depression)	Five years

Collaborators and Investigators

• Sponsor: Rebecka Hultgren
• Collaborators: Karolinska University Hospital; Karolinska Institutet; Sahlgrenska University Hospital, Sweden; Stockholm South General Hospital
• Investigators: Principal Investigator: Rebecka Hultgren, Prof, Karolinska Instutet

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): December 1, 2028

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Vascular disease; Open vascular surgery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Aneurysm
• Other Study ID Numbers: NPAA0831365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No