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

Sponsor
John Paul II Hospital, Krakow (Other)
Overall Status
Recruiting
CT.gov ID
NCT05183373
Collaborator
Jagiellonian University (Other), National Science Centre, Poland (Other)
180
1
44.6
4

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Evaluation of inflammation and clotting

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 Design

Study Type:
Observational
Anticipated Enrollment :
180 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease
Anticipated Study Start Date :
Jan 10, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Aneurysmal coronary artery disease

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

Other: 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)

Abdominal aortic aneurysm

Patients with diagnosed with abdominal aortic aneurysm

Other: 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)

Coronary artery disease

Patients with diagnosed with coronary artery disease

Other: 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)

Outcome Measures

Primary Outcome Measures

  1. Inflammation [Baseline (at enrolment)]

    Level of inflammation biomarkers (such as 8-isoprostane, Il-6) in each group

  2. Clotting [Baseline (at enrolment)]

    Fibrin clot properties (such as clot lysis time, clot permeability) in each group

  3. Composite Clinical outcome after 1 year [1 year after the enrolment]

    Death, stroke, myocardial infarction

  4. Composite Clinical outcome after 5 years [5 years after the enrolment]

    Death, stroke, myocardial infarction

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Cardiac and Vascular Diseases, John Paul II Hospital Krakow Poland 31-202

Sponsors and Collaborators

  • John Paul II Hospital, Krakow
  • Jagiellonian University
  • National Science Centre, Poland

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
John Paul II Hospital, Krakow
ClinicalTrials.gov Identifier:
NCT05183373
Other Study ID Numbers:
  • 2020/39/NZ5/02863
First Posted:
Jan 10, 2022
Last Update Posted:
Jan 10, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by John Paul II Hospital, Krakow
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2022