Ignite Creation Date:
2024-05-06 @ 2:15 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04269447
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2022-12-01
First Post:
2019-12-05
Brief Title:
Prospective Aortic Biobank of POP-STAR
Sponsor:
Karolinska University Hospital
Organization:
Karolinska University Hospital
Study Overview
Official Title:
POP-STAR The Prospective Data Collection on Patients With Abdominal Aortic Aneurysms at the Stockholm Aneurysm Research Group STAR
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The overall objective of the POP-STAR project is individualized surveillance for patients diagnosed with abdominal aortic aneurysms by means of more precise patient-specific AAA growth prediction
Detailed Description:
Abdominal aortic aneurysms AAA ICD10 I714 are asymptomatic dilatations of the infrarenal aorta 3cm with potential to rupture This multifactorial disease is known to be caused by the progressive degradation of the aortic wall AAAs have life-threatening consequences in the event of rupture rAAA the mortality is 100 if left untreated The risk of rupture is closely related to the size of the AAA When a patient is diagnosed with an AAA life-long surveillance is initiated with regular ultrasound or computed tomography CT scans performed at vascular services Prophylactic surgery is performed when the risk of rupture exceeds the risk of treatment according to international guidelines surgical evaluation and repair is indicated at a threshold of 55 mm 50 mm in women to avoid rupture and subsequent death
The mortality after planned elective AAA repair is estimated at 15 By contrast the mortality after emergency surgery for rAAA reaches 30 As such there is much to be gained by early identification of AAAs to enable timely intervention and reduce aneurysm-related morbidity and mortality in the population The important non-modifiable risk factors for developing the disease include male sex smoking high age and family history of AAA Since 2006 one-time ultrasound screening for AAAs among elderly men has been gradually introduced in Sweden - the programme reached nationwide coverage in 2015 A prevalence of 14-20 has been recorded in the screened population and an overall reduction of 40 in aneurysm-related death has been demonstrated annual decline in aneurysm-related mortality of 4 It is not however cost-efficient to screen the female population due to low prevalence and high age at onset of disease
Previous investigations have indicated that 10-25 of all patients admitted for rupture were already known by the health care system but were subsequently lost to follow-up Importantly some large aneurysms never rupture while some small aneurysms 55 mm unpredictably do so - in the randomized controlled trial of UKSAT an annual rupture risk of 1 was documented for small AAAs
Despite these shortcomings at a patient-specific level there is still only one verified measure the diameter for evaluating growth risk of rupture and indication for surgery Consequently the current follow-up protocol for AAA patients is generalized and fails to consider factors such as age female sex smoking aneurysm morphology and lung function impairment The major challenge within the field is risk assessment with high precision in order to provide treatment for the right patient and the right time
The standard surveillance entails repeated diameter measurements the larger the aneurysm the shorter the control intervals The POP-STAR project explores new methods of AAA surveillance by prospective data collection comprising of patient demographics radiological properties and follow-up information on patients diagnosed with AAAs All patients will be subjected to standard care flow - POP-STAR adds patient risk profiling and scheduled imaging follow-up The goal is to be able to characterize the radiological and biomechanical profiles of AAAs for accurate risk stratification ultimately aiming at individualized AAA patient care
The mortality after planned elective AAA repair is estimated at 15 By contrast the mortality after emergency surgery for rAAA reaches 30 As such there is much to be gained by early identification of AAAs to enable timely intervention and reduce aneurysm-related morbidity and mortality in the population The important non-modifiable risk factors for developing the disease include male sex smoking high age and family history of AAA Since 2006 one-time ultrasound screening for AAAs among elderly men has been gradually introduced in Sweden - the programme reached nationwide coverage in 2015 A prevalence of 14-20 has been recorded in the screened population and an overall reduction of 40 in aneurysm-related death has been demonstrated annual decline in aneurysm-related mortality of 4 It is not however cost-efficient to screen the female population due to low prevalence and high age at onset of disease
Previous investigations have indicated that 10-25 of all patients admitted for rupture were already known by the health care system but were subsequently lost to follow-up Importantly some large aneurysms never rupture while some small aneurysms 55 mm unpredictably do so - in the randomized controlled trial of UKSAT an annual rupture risk of 1 was documented for small AAAs
Despite these shortcomings at a patient-specific level there is still only one verified measure the diameter for evaluating growth risk of rupture and indication for surgery Consequently the current follow-up protocol for AAA patients is generalized and fails to consider factors such as age female sex smoking aneurysm morphology and lung function impairment The major challenge within the field is risk assessment with high precision in order to provide treatment for the right patient and the right time
The standard surveillance entails repeated diameter measurements the larger the aneurysm the shorter the control intervals The POP-STAR project explores new methods of AAA surveillance by prospective data collection comprising of patient demographics radiological properties and follow-up information on patients diagnosed with AAAs All patients will be subjected to standard care flow - POP-STAR adds patient risk profiling and scheduled imaging follow-up The goal is to be able to characterize the radiological and biomechanical profiles of AAAs for accurate risk stratification ultimately aiming at individualized AAA patient care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None