Clinical trial NCT05183373: Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease
Official title: Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Aneurysm
Abdominal Aortic Aneurysm
Coronary Disease
Keywords: Coronary Artery Aneurysm
Inflammation
Fibrin Clot Lysis Time
Coronary Disease
Abdominal Aortic Aneurysm
Lead sponsor: John Paul II Hospital, Krakow
Sponsor class: OTHER
Collaborators: name: Jagiellonian University
name: National Science Centre, Poland
First posted: 2022-01-10
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comer, consecutive patients with the contiontds under the evaluation in this study will be screen for enrolment.

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inflammation
timeFrame: Baseline (at enrolment)
measure: Clotting
timeFrame: Baseline (at enrolment)
measure: Composite Clinical outcome after 1 year
timeFrame: 1 year after the enrolment
measure: Composite Clinical outcome after 5 years
timeFrame: 5 years after the enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: Department of Cardiac and Vascular Diseases, John Paul II Hospital
Study officials:
affiliation: John Paul II Hospital, Krakow
name: Piotr Musiałek, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
citation: 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.
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.