CARE-ANUERYSM: Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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
- Inflammation [Baseline (at enrolment)]
Level of inflammation biomarkers (such as 8-isoprostane, Il-6) in each group
- Clotting [Baseline (at enrolment)]
Fibrin clot properties (such as clot lysis time, clot permeability) in each group
- Composite Clinical outcome after 1 year [1 year after the enrolment]
Death, stroke, myocardial infarction
- Composite Clinical outcome after 5 years [5 years after the enrolment]
Death, stroke, myocardial infarction
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-85 years old
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Angiographically confirmed coronary artery ectasia or aneurysm (Arm I)
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Abdominal aortic aneurysm (Arm II)
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Angiographically confirmed coronary artery disease (Arm III)
Exclusion Criteria:
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Less than 12 months from ACS
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Actual oral anticoagulant therapy
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Actual antiplatelet therapy other than aspirin
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Heart failure NYHA IV
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Untreated hyperthyroidism or hypothyroidism
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Severe comorbidities
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Lack of consent
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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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
- 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.
- 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.
- 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.
- 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.
- 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.
- 2020/39/NZ5/02863