search
Back to results

Prospective Case-control Study in Patients With PAA

Primary Purpose

Popliteal Artery Aneurysm, Peripheral Arterial Disease, Quality of Life

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Bypass surgery
Sponsored by
Rebecka Hultgren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Popliteal Artery Aneurysm focused on measuring Open vascular surgery, Vascular disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sahlgrenska University HospitalRecruiting
  • Karolinska University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Popliteal artery aneurysm

Peripheral artery disease

Arm Description

Asymptomatic popliteal artery aneurysm patients will undergo surgery with a femoropopliteal/femorodistal bypass

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

Outcomes

Primary Outcome Measures

SF-36
A 36-item questionnaire that measures 8 dimensions of physical and mental health. ( 0-100) Positive if high

Secondary Outcome Measures

EQ-5D
EQ-5D is a standardized instrument for measuring generic health status (0-100) 100 best Health and 0 worst helath

Full Information

First Posted
November 13, 2019
Last Updated
November 30, 2022
Sponsor
Rebecka Hultgren
Collaborators
Karolinska University Hospital, Karolinska Institutet, Stockholm South General Hospital, Sahlgrenska University Hospital, Sweden
search

1. Study Identification

Unique Protocol Identification Number
NCT04188808
Brief Title
Prospective Case-control Study in Patients With PAA
Official Title
A Prospective Case-control Study of the Quality of Life in Patients With Aneurysmatic or Occlusive Disease in the Lower Limb
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Rebecka Hultgren
Collaborators
Karolinska University Hospital, Karolinska Institutet, Stockholm South General Hospital, Sahlgrenska University Hospital, Sweden

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Popliteal Artery Aneurysm, Peripheral Arterial Disease, Quality of Life
Keywords
Open vascular surgery, Vascular disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Popliteal artery aneurysm
Arm Type
Experimental
Arm Description
Asymptomatic popliteal artery aneurysm patients will undergo surgery with a femoropopliteal/femorodistal bypass
Arm Title
Peripheral artery disease
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Bypass surgery
Intervention Description
All patients scheduled for elective surgery of PAA and PAD.
Primary Outcome Measure Information:
Title
SF-36
Description
A 36-item questionnaire that measures 8 dimensions of physical and mental health. ( 0-100) Positive if high
Time Frame
Five years
Secondary Outcome Measure Information:
Title
EQ-5D
Description
EQ-5D is a standardized instrument for measuring generic health status (0-100) 100 best Health and 0 worst helath
Time Frame
Five years
Other Pre-specified Outcome Measures:
Title
PHQ-9 PHQ-9
Description
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)
Time Frame
Five years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecka Hultgren, Prof
Phone
+46851776596
Email
rebecka.hultgren@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Iva Jergovic, MD
Phone
+46851770947
Email
iva.jergovic@sll.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecka Hultgren, Prof
Organizational Affiliation
Karolinska Instutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joakim Nordanstig, MD, assoc prof.
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iva Jergovic, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prospective Case-control Study in Patients With PAA

We'll reach out to this number within 24 hrs