Coronary Disease Clinical Trial
— CARE-ANUERYSMOfficial title:
Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease
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).
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 |
Country | Name | City | State |
---|---|---|---|
Poland | Department of Cardiac and Vascular Diseases, John Paul II Hospital | Krakow |
Lead Sponsor | Collaborator |
---|---|
John Paul II Hospital, Krakow | Jagiellonian University, National Science Centre, Poland |
Poland,
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
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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