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Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05183373
Acronym
CARE-ANUERYSM
Enrollment
180
Registered
2022-01-10
Start date
2022-01-10
Completion date
2025-09-30
Last updated
2022-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Aortic Aneurysm, Coronary Artery Aneurysm, Coronary Disease

Keywords

Coronary Artery Aneurysm, Inflammation, Fibrin Clot Lysis Time, Coronary Disease, Abdominal Aortic Aneurysm

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.

Interventions

OTHEREvaluation 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)

Sponsors

Jagiellonian University
CollaboratorOTHER
National Science Centre, Poland
CollaboratorOTHER_GOV
John Paul II Hospital, Krakow
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
InflammationBaseline (at enrolment)Level of inflammation biomarkers (such as 8-isoprostane, Il-6) in each group
ClottingBaseline (at enrolment)Fibrin clot properties (such as clot lysis time, clot permeability) in each group
Composite Clinical outcome after 1 year1 year after the enrolmentDeath, stroke, myocardial infarction
Composite Clinical outcome after 5 years5 years after the enrolmentDeath, stroke, myocardial infarction

Countries

Poland

Contacts

Primary ContactPiotr Musiałek, MD DPhil
p.musialek@szpitaljp2.krakow.pl+48126143501

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026