Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

Recruiting

• Conditions: Abdominal Aortic Aneurysm; Coronary Artery Aneurysm; Coronary Disease
• Interventions: Other: Evaluation of inflammation and clotting

• Registration Number: NCT05183373
• Lead Sponsor: John Paul II Hospital, Krakow

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.

Study Timeline

• Status Verified: 2022-01
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-06
• Last Update Submitted: 2022-01-06
• Study Start: 2022-01-10
• Study First Posted: 2022-01-10
• Last Update Posted: 2022-01-10
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Abdominal aortic aneurysm	Evaluation of inflammation and clotting	Patients with diagnosed with abdominal aortic aneurysm
Coronary artery disease	Evaluation of inflammation and clotting	Patients with diagnosed with coronary artery disease
Aneurysmal coronary artery disease	Evaluation of inflammation and clotting	Patients with coronary artery ectasia or/and aneurysm diagnosed during coronary angiography

Primary Outcome Measures

Name	Time	Method
Inflammation	Baseline (at enrolment)	Level of inflammation biomarkers (such as 8-isoprostane, Il-6) in each group
Composite Clinical outcome after 5 years	5 years after the enrolment	Death, stroke, myocardial infarction
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

Trial Locations

Locations (1)

Department of Cardiac and Vascular Diseases, John Paul II Hospital; 🇵🇱 Krakow, Poland