Abdominal Aortic Aneurysm, Coronary Artery Aneurysm, Coronary Disease
Conditions
Keywords
Coronary Artery Aneurysm, Inflammation, Fibrin Clot Lysis Time, Coronary Disease, Abdominal Aortic Aneurysm
Brief summary
The main objective of the CARE-ANEURYSM project is to evaluate inflammation and clotting abnormalities in patients with aneurysmal coronary artery disease in relation to patients with abdominal aortic aneurysm or coronary artery disease (acting as controls).
Detailed description
The trial will enrol 180 patients, 60 in each of three groups: 1) aneurysmal coronary artery disease; 2) abdominal aortic aneurysm; 3) coronary artery disease. In addition, up to 250 patients with aneurysmal coronary disease will be follow for clinical outcomes in relation to controls (prognosis group). The primary research question of this project is to evaluate wheter the inflammation and clotting abnormalities in patients with aneurysmal coronary artery disease differ from ones in abdominal aortic aneurysm or coronary artery diseases. Study endpoints include the level of inflammation biomarkers and fibrin clot properties in each cohort.
Interventions
Evaluation of inflammation biomarkers (such as 8-isoprostane, Il-6) and fibrin clot properties (such as clot lysis time, clot permeability)
Sponsors
Study design
Eligibility
Inclusion criteria
* Age 18-85 years old * Angiographically confirmed coronary artery ectasia or aneurysm (Arm I) * Abdominal aortic aneurysm (Arm II) * Angiographically confirmed coronary artery disease (Arm III)
Exclusion criteria
* Less than 12 months from ACS * Actual oral anticoagulant therapy * Actual antiplatelet therapy other than aspirin * Heart failure NYHA IV * Untreated hyperthyroidism or hypothyroidism * Severe comorbidities * Lack of consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation | Baseline (at enrolment) | Level of inflammation biomarkers (such as 8-isoprostane, Il-6) in each group |
| Clotting | Baseline (at enrolment) | Fibrin clot properties (such as clot lysis time, clot permeability) in each group |
| Composite Clinical outcome after 1 year | 1 year after the enrolment | Death, stroke, myocardial infarction |
| Composite Clinical outcome after 5 years | 5 years after the enrolment | Death, stroke, myocardial infarction |
Countries
Poland