Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-10

Study Completion Date

2025-09-30

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).

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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.

Conditions

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Coronary Artery Aneurysm Abdominal Aortic Aneurysm Coronary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Aneurysmal coronary artery disease

Patients with coronary artery ectasia or/and aneurysm diagnosed during coronary angiography

Evaluation of inflammation and clotting

Intervention Type OTHER

Evaluation of inflammation biomarkers (such as 8-isoprostane, Il-6) and fibrin clot properties (such as clot lysis time, clot permeability)

Abdominal aortic aneurysm

Patients with diagnosed with abdominal aortic aneurysm

Evaluation of inflammation and clotting

Intervention Type OTHER

Evaluation of inflammation biomarkers (such as 8-isoprostane, Il-6) and fibrin clot properties (such as clot lysis time, clot permeability)

Coronary artery disease

Patients with diagnosed with coronary artery disease

Evaluation of inflammation and clotting

Intervention Type OTHER

Evaluation of inflammation biomarkers (such as 8-isoprostane, Il-6) and fibrin clot properties (such as clot lysis time, clot permeability)

Interventions

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Evaluation of inflammation and clotting

Evaluation of inflammation biomarkers (such as 8-isoprostane, Il-6) and fibrin clot properties (such as clot lysis time, clot permeability)

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No