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| Name | Class |
|---|---|
| Jagiellonian University | OTHER |
| National Science Centre, Poland | OTHER_GOV |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aneurysmal coronary artery disease | Patients with coronary artery ectasia or/and aneurysm diagnosed during coronary angiography |
| |
| Abdominal aortic aneurysm | Patients with diagnosed with abdominal aortic aneurysm |
| |
| Coronary artery disease | Patients with diagnosed with coronary artery disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluation of inflammation and clotting | Other | Evaluation of inflammation biomarkers (such as 8-isoprostane, Il-6) and fibrin clot properties (such as clot lysis time, clot permeability) |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation | Level of inflammation biomarkers (such as 8-isoprostane, Il-6) in each group | Baseline (at enrolment) |
| Clotting | Fibrin clot properties (such as clot lysis time, clot permeability) in each group | Baseline (at enrolment) |
| Composite Clinical outcome after 1 year | Death, stroke, myocardial infarction | 1 year after the enrolment |
| Composite Clinical outcome after 5 years | Death, stroke, myocardial infarction | 5 years after the enrolment |
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Inclusion Criteria:
Exclusion Criteria:
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All-comer, consecutive patients with the contiontds under the evaluation in this study will be screen for enrolment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Piotr Musiałek, MD DPhil | Contact | +48126143501 | p.musialek@szpitaljp2.krakow.pl |
| Name | Affiliation | Role |
|---|---|---|
| Piotr Musiałek, MD, DPhil | John Paul II Hospital, Krakow | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiac and Vascular Diseases, John Paul II Hospital | Recruiting | Krakow | 31-202 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29051141 | Background | 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. | |
| 29976357 |
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| ID | Term |
|---|---|
| D003323 | Coronary Aneurysm |
| D017544 | Aortic Aneurysm, Abdominal |
| D003327 | Coronary Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000783 | Aneurysm |
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| ID | Term |
|---|---|
| D001760 | Bleeding Time |
| ID | Term |
|---|---|
| D010979 | Platelet Function Tests |
| D006403 | Hematologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Blood sample
| Background |
| Kawsara A, Nunez 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. |
| 30393992 | Background | 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. |
| 29337902 | Background | 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):260. doi: 10.3390/ijms19010260. |
| 24553454 | Background | 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. |
| 37660376 | Derived | Chmiel J, Natorska J, Zabczyk M, Musialek P. Fibrin clot properties in coronary artery ectatic disease: Pilot data from the CARE-ANEURYSM Study. Kardiol Pol. 2023;81(11):1145-1148. doi: 10.33963/v.kp.96983. Epub 2023 Sep 3. No abstract available. |
| D014652 |
| Vascular Diseases |
| D001014 | Aortic Aneurysm |
| D001018 | Aortic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |