Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease (CARE-ANUERYSM)

John Paul II Hospital, Krakow

Status: Enrolling

Conditions: Coronary Artery Aneurysm; Abdominal Aortic Aneurysm; Coronary Disease

Treatments: Other: Evaluation of inflammation and clotting

Study type: Observational

Funder types: Other

Identifiers

NCT05183373

2020/39/NZ5/02863

Details and patient eligibility

About

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).

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

180 participants in 3 patient groups

Aneurysmal coronary artery disease

Description:

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

Treatment:

Other: Evaluation of inflammation and clotting

Abdominal aortic aneurysm

Description:

Patients with diagnosed with abdominal aortic aneurysm

Treatment:

Other: Evaluation of inflammation and clotting

Coronary artery disease

Description:

Patients with diagnosed with coronary artery disease

Treatment:

Other: Evaluation of inflammation and clotting