Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

Brief Title

Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

Official Title

Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

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 Type

Observational


Primary Outcome

Inflammation


Condition

Coronary Artery Aneurysm

Intervention

Evaluation of inflammation and clotting

Study Arms / Comparison Groups

 Aneurysmal coronary artery disease
Description:  Patients with coronary artery ectasia or/and aneurysm diagnosed during coronary angiography

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

180

Start Date

January 10, 2022

Completion Date

September 30, 2025

Primary Completion Date

September 30, 2024

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Piotr Musiałek, MD, DPhil, +48126143501, [email protected]

Location Countries

Poland

Location Countries

Poland

Administrative Informations


NCT ID

NCT05183373

Organization ID

2020/39/NZ5/02863


Responsible Party

Sponsor

Study Sponsor

John Paul II Hospital, Krakow

Collaborators

 Jagiellonian University

Study Sponsor

Piotr Musiałek, MD, DPhil, Principal Investigator, John Paul II Hospital, Krakow


Verification Date

January 2022