Study of biomarker profiling to unravel the intertwined pathophysiology of coronary artery disease and abdominal aortic aneurysm
Recruiting
- Conditions
- Abdominal aortic aneurysm10002363
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 440
Inclusion Criteria
This study will include: 1. patients with an AAA diameter >=40mm and treated by
watchful waiting strategy; 2. patients planned to undergo EVAR; 3. patients who
underwent EVAR in past years.
Exclusion Criteria
Main exclusion criteria: patients with saccular abdominal aortic aneurysm,
isolated iliac artery aneurysm, traumatic aneurysm, anastomotic aneurysm and
infectious aneurysm, clinical diagnosed thoracic aneurysm, dialysis dependent
patients, women of childbearing age or patients with coexistent condition with
life expectancy <=1 year.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study endpoint is volume of the aneurysm sac, measured repeatedly<br /><br>by CT scan imaging during 24 months of follow-up. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include maximal diameter and length of the aneurysm,<br /><br>all-cause mortality, quality of life and depression and:<br /><br>- AAA-related adverse events in watchful waiting group: AAA related death, AAA<br /><br>rupture, or any AAA-related intervention.<br /><br>- AAA-related adverse events in EVAR patients: direct (type 1 or 3) or<br /><br>undetermined type endoleaks, migration >10 mm, device integrity failure,<br /><br>AAA-related death, late postimplantation AAA rupture, or any AAA-related<br /><br>secondary intervention.<br /><br>- Cardiovascular events: i.e. cardiovascular death, myocardial infarction,<br /><br>percutaneous coronary intervention (PCI), coronary artery bypass grafting<br /><br>(CABG).</p><br>