Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

Coronary Disease Clinical Trial

— CARE-ANUERYSM  

Official title:

Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05183373
• Other study ID #: 2020/39/NZ5/02863
• Status: Recruiting
• Start date: January 10, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: January 2022
• Source: John Paul II Hospital, Krakow
• Contact: Piotr Musialek, MD DPhil
• Phone: +48126143501
• Email: p.musialek[@]szpitaljp2.krakow.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Coronary Aneurysm
• Coronary Artery Aneurysm
• Coronary Artery Disease
• Coronary Disease
• Inflammation

Intervention

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)

Locations

Country	Name	City	State
Poland	Department of Cardiac and Vascular Diseases, John Paul II Hospital	Krakow

Sponsors (3)

Lead Sponsor	Collaborator
John Paul II Hospital, Krakow	Jagiellonian University, National Science Centre, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (5)

Boles U, Johansson A, Wiklund U, Sharif Z, David S, McGrory S, Henein MY. Cytokine Disturbances in Coronary Artery Ectasia Do Not Support Atherosclerosis Pathogenesis. Int J Mol Sci. 2018 Jan 16;19(1). pii: E260. doi: 10.3390/ijms19010260. — View Citation

Brunetti ND, Salvemini G, Cuculo A, Ruggiero A, De Gennaro L, Gaglione A, Di Biase M. Coronary artery ectasia is related to coronary slow flow and inflammatory activation. Atherosclerosis. 2014 Apr;233(2):636-640. doi: 10.1016/j.atherosclerosis.2014.01.018. Epub 2014 Jan 28. — View Citation

Doi T, Kataoka Y, Noguchi T, Shibata T, Nakashima T, Kawakami S, Nakao K, Fujino M, Nagai T, Kanaya T, Tahara Y, Asaumi Y, Tsuda E, Nakai M, Nishimura K, Anzai T, Kusano K, Shimokawa H, Goto Y, Yasuda S. Coronary Artery Ectasia Predicts Future Cardiac Events in Patients With Acute Myocardial Infarction. Arterioscler Thromb Vasc Biol. 2017 Dec;37(12):2350-2355. doi: 10.1161/ATVBAHA.117.309683. Epub 2017 Oct 19. — View Citation

Gunasekaran P, Stanojevic D, Drees T, Fritzlen J, Haghnegahdar M, McCullough M, Barua R, Mehta A, Hockstad E, Wiley M, Earnest M, Tadros P, Genton R, Gupta K. Prognostic significance, angiographic characteristics and impact of antithrombotic and anticoagulant therapy on outcomes in high versus low grade coronary artery ectasia: A long-term follow-up study. Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1219-1227. doi: 10.1002/ccd.27929. Epub 2018 Nov 4. — View Citation

Kawsara A, Núñez Gil IJ, Alqahtani F, Moreland J, Rihal CS, Alkhouli M. Management of Coronary Artery Aneurysms. JACC Cardiovasc Interv. 2018 Jul 9;11(13):1211-1223. doi: 10.1016/j.jcin.2018.02.041. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation	Level of inflammation biomarkers (such as 8-isoprostane, Il-6) in each group	Baseline (at enrolment)
Primary	Clotting	Fibrin clot properties (such as clot lysis time, clot permeability) in each group	Baseline (at enrolment)
Primary	Composite Clinical outcome after 1 year	Death, stroke, myocardial infarction	1 year after the enrolment
Primary	Composite Clinical outcome after 5 years	Death, stroke, myocardial infarction	5 years after the enrolment