Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease
CARE-ANUERYSM
1 other identifier
observational
180
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2022
CompletedFirst Posted
Study publicly available on registry
January 10, 2022
CompletedStudy Start
First participant enrolled
January 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2025
CompletedJanuary 10, 2022
January 1, 2022
2.7 years
January 5, 2022
January 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (3)
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
Interventions
Evaluation of inflammation biomarkers (such as 8-isoprostane, Il-6) and fibrin clot properties (such as clot lysis time, clot permeability)
Eligibility Criteria
All-comer, consecutive patients with the contiontds under the evaluation in this study will be screen for enrolment.
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- John Paul II Hospital, Krakowlead
- Jagiellonian Universitycollaborator
- National Science Centre, Polandcollaborator
Study Sites (1)
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, 31-202, Poland
Related Publications (6)
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.
PMID: 29051141BACKGROUNDKawsara 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.
PMID: 29976357BACKGROUNDGunasekaran 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.
PMID: 30393992BACKGROUNDBoles 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.
PMID: 29337902BACKGROUNDBrunetti 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.
PMID: 24553454BACKGROUNDChmiel 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.
PMID: 37660376DERIVED
Biospecimen
Blood sample
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Piotr Musiałek, MD, DPhil
John Paul II Hospital, Krakow
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2022
First Posted
January 10, 2022
Study Start
January 10, 2022
Primary Completion
September 30, 2024
Study Completion
September 30, 2025
Last Updated
January 10, 2022
Record last verified: 2022-01