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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05183373
Other study ID # 2020/39/NZ5/02863
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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