The research focuses on the active screening of high prevalence patients and the diagnosis of AAA. This study aims to establish an effective screening protocol and determining a higher prevalence in patients with PAD and patients with carotid…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
AAA prevalence in patients with PAD and patients with carotid stenosis.
Secondary outcome
- Quality of life as measured by Medical Outcomes Study, Short Form 36 (SF-36)
- Illness Perception measured 'Illness Perceptions Questionnaire, short
version (IPQ-K)
- Division AAA diameter under age categories
- Percentage of patients who choose to have a screening ultrasound
- Usability and reliability of Vscan* (GE Healthcare)
Background summary
An aneurysm of the abdominal aorta (AAA) is a local dilatation of the aorta in
the abdomen (diameter >= 3 cm). The aneurysm generally causes no symptoms and is
often discovered by accident. The risk of an aneurysm is that it can tear. In
case that happens the risk of death is 80%. In 2000, the number of people with
AAA in the Netherlands is estimated at 86,100 (69,400 men and 16,700 women) and
this incidence will only increase. In the same year 830 persons (620 men and
210 women) deceased due to an AAA.
The high mortality in patients with ruptured aneurysm in comparison with the
low mortality due to a preventive operation of a non-ruptured aneurysm has led
to research of the (cost)effectiveness of population-based screening studies
for AAA. A Cochrane review showed that screening people for AAA leads to a
significant reduction in AAA-related mortality in men aged 65 to 79. It also
has been shown that screening of men in the Netherlands is costeffective. There
is still insufficient evidence to show an effect on the total mortality in
women. A nationwide screening program for AAA in the Netherlands has not yet
started.
Screening of groups with an increased prevalence may be more effective. It is
known that the prevalence is higher among patients with PAD and patients with
carotid stenosis compared to the prevalence from population-based screening
studies. Both groups of patients have an increased risk of other cardiovascular
diseases, making that the life expectancy after a preventive surgery may not be
increased. Both open and endovascular surgery have risks and complications so
that the life expectancy can also be shortened.
Moreover, the diagnosis after screening for AAA is likely to affect the psyche
of the patient and his/her partner. A Cochrane review shows there are no data
available about the quality of life after assigning the diagnosis of AAA in
screening studies. The available literature describes only the post-screening
difference in quality of life after negative versus positive screening. So far,
baseline measurements were not included in the analysis.
Study objective
The research focuses on the active screening of high prevalence patients and
the diagnosis of AAA. This study aims to establish an effective screening
protocol and determining a higher prevalence in patients with PAD and patients
with carotid stenosis that visit the outpatient clinic of the Catharina
Hospital. At the same time, there is the opportunity to inform the patient in
detail about the increased risk of having an AAA and to determine the influence
of the AAA diagnosis on the quality of life.
Study design
Patients with PAD and patients with carotid stenosis who meet all inclusion
criteria and none of the exclusion criteria will be asked to participate in
this research by using shared-decision making. They are given at least 3 days
for reflection, before deciding to participate in the study and sign informed
consent. Patients who give consent will be asked to fill in the SF-36
questionnaire. Then the patient will receive an ultrasound of the aorta by
using a Vscan * , performed by a nurse practitioner of the vascular surgery
department, to determine the initial diameter. The following possibilities
exist:
- The diameter is <3 cm: the patient is informed that he/she has no aneurysm.
- The diameter >= 3 cm: the patient is referred for an ultrasound examination
of the aorta at the Vascular Laboratory.
- In case the diameter is confirmed, the patient will follow the standard
procedure that has been followed in the Catharina Hospital for decades in case
of AAA coincidence detection;
- Patients with a diameter <5 cm are periodically (every 3, 6 or 12
months) checked according to hospital protocol.
- Patients with a diameter >= 5 cm suitable for surgery (according to
international guidelines), get a CT scan followed by an open or endovascular
surgery for the aneurysm according to usual care.
Three months after the results of the ultrasound, the patient is asked to fill
in the SF-36 questionnaire and the IPQ-K questionnaire.
Besides this, we gather the medical information of new patients, who already
know if they have an aneurysm or not.
Study burden and risks
Patients will be asked 2 times to fill in a questionnaire. Patients are given a
non-invasive ultrasound of the abdominal aorta. This is least stressful for the
patient and brings no direct risks with them. In case that an aneurysm of the
abdominal aorta is detected, the patient may experience this as a mental
burden. In case it comes to an operation, the patient runs the risks associated
with the operation. By informing the patient in detail about the burdens and
risks by using shared-decision making, the patient may take a well considered
decision about participation in this study.
Michelangelolaan 2
5623 EJ Eindhoven
NL
Michelangelolaan 2
5623 EJ Eindhoven
NL
Listed location countries
Age
Inclusion criteria
- Patients with peripheral arterial disease (ankle brachial pressure index < 0.90 and/or a decline of > 0.15 after exercise test) and/or carotis stenosis (>= 50%)
- Men and women
- Age > 55 years
Exclusion criteria
- Patients unfit for endovascular or open surgery (as judged by vascular surgeon)
- Failure to master the dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL39959.060.12 |