Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

Conditions
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Coronary Artery Aneurysm, Abdominal Aortic Aneurysm, Coronary Disease

Intervention / Treatment
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* Other: Evaluation of inflammation and clotting


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aneurysmal coronary artery disease<br>Patients with coronary artery ectasia or/and aneurysm diagnosed during coronary angiography | Other: Evaluation of inflammation and clotting<br>* Evaluation of inflammation biomarkers (such as 8-isoprostane, Il-6) and fibrin clot properties (such as clot lysis time, clot permeability)<br>|
| Abdominal aortic aneurysm<br>Patients with diagnosed with abdominal aortic aneurysm | Other: Evaluation of inflammation and clotting<br>* Evaluation of inflammation biomarkers (such as 8-isoprostane, Il-6) and fibrin clot properties (such as clot lysis time, clot permeability)<br>|
| Coronary artery disease<br>Patients with diagnosed with coronary artery disease | Other: Evaluation of inflammation and clotting<br>* Evaluation of inflammation biomarkers (such as 8-isoprostane, Il-6) and fibrin clot properties (such as clot lysis time, clot permeability)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation | Level of inflammation biomarkers (such as 8-isoprostane, Il-6) in each group | Baseline (at enrolment) | 
| Clotting | Fibrin clot properties (such as clot lysis time, clot permeability) in each group | Baseline (at enrolment) | 
| Composite Clinical outcome after 1 year | Death, stroke, myocardial infarction | 1 year after the enrolment | 
| Composite Clinical outcome after 5 years | Death, stroke, myocardial infarction | 5 years after the enrolment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Artery Aneurysm, Inflammation, Fibrin Clot Lysis Time, Coronary Disease, Abdominal Aortic Aneurysm