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Prospective Aortic Biobank of POP-STAR

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04269447
Recruitment Status : Enrolling by invitation
First Posted : February 13, 2020
Last Update Posted : February 13, 2020
Sponsor:
Information provided by (Responsible Party):
Rebecka Hultgren, Karolinska University Hospital

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.

Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm Without Rupture Abdominal Aortic Aneurysm, Ruptured Aortic Aneurysm Aneurysm Abdominal Aneurysm Diagnostic Test: Structured imaging follow-up

Detailed Description:

Abdominal aortic aneurysms (AAA, ICD10 I71.4) 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 1.5%. 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 1.4-2.0% 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: POP-STAR: The Prospective Data Collection on Patients With Abdominal Aortic Aneurysms at the Stockholm Aneurysm Research Group (STAR)
Actual Study Start Date : November 18, 2019
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Structured imaging follow-up
    Structured imaging follow-up protocol with ultrasound (US) and computed tomography (CT) examinations as compared to current standard surveillance protocol for individualized estimations of AAA growth.
    Other Name: Finite element analysis (FEA)


Primary Outcome Measures :
  1. Aneurysm expansion rate [ Time Frame: Primary outcome evaluated at two years of follow-up. ]
    Comparison of correctness of predicted growth (diameter vs ASI)

  2. Aneurysm expansion rate [ Time Frame: Primary outcome second analysis at two years follow-up. ]
    Assessment if a more correct predicted growth alters surveillance (ASI vs diameter)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All men and women diagnosed with an intact abdominal aortic aneurysm (AAA) and who fulfill the inclusion diameter criterion and none of the exclusion criteria are verified at the Department of Vascular Surgery, Karolinska University Hospital, Solna, and consecutively invited to participate.
Criteria

Inclusion Criteria:

  • Abdominal aortic aneurysm 35-49 mm in men
  • Abdominal aortic aneurysm 30-49 mm in women

Exclusion Criteria:

  • Previous aortic or iliac surgery
  • Present comorbidities with less than 2-years life expectancy
  • Unable or unwilling to give informed consent
  • Computed tomography examination with intravenous contrast contraindicated due to renal insufficiency (defined as creatinine/eGFR level XXX)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04269447


Locations
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Sweden
Department of Vascular Surgery, Karolinska University Hospital
Solna, Stockholm, Sweden, 171 76
Sponsors and Collaborators
Karolinska University Hospital

Publications:

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Responsible Party: Rebecka Hultgren, Adjunct Professor, Senior Consultant Vascular Surgery, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT04269447    
Other Study ID Numbers: EPN201904182
First Posted: February 13, 2020    Key Record Dates
Last Update Posted: February 13, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rebecka Hultgren, Karolinska University Hospital:
Growth Prediction
Rupture Risk Prediction
Imaging
Aortic disease
Vascular surgery
Vascular disease
Cardiovascular disease
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aneurysm, Ruptured
Aortic Rupture
Rupture
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Wounds and Injuries