Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease (CARE-ANUERYSM)

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).

Study Overview

• Status: Recruiting
• Conditions: Coronary Disease; Abdominal Aortic Aneurysm; Coronary Artery Aneurysm
• Intervention / Treatment: Other: Evaluation of inflammation and clotting

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 Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Piotr Musiałek, MD DPhil; Phone Number: +48126143501; Email: p.musialek@szpitaljp2.krakow.pl

Study Locations

• Poland
  • Krakow, Poland, 31-202
    • Recruiting
    • Department of Cardiac and Vascular Diseases, John Paul II Hospital
    • Contact: Piotr Musialek, MD, DPhil; Phone Number: +48126142287; Email: pmusialek@szpitaljp2.krakow.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: John Paul II Hospital, Krakow
• Collaborators: Jagiellonian University; National Science Centre, Poland
• Investigators: Principal Investigator: Piotr Musiałek, MD, DPhil, John Paul II Hospital, Krakow

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 10, 2022
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 6, 2022
• First Posted (Actual): January 10, 2022

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Inflammation; Coronary Disease; Abdominal Aortic Aneurysm; Coronary Artery Aneurysm; Fibrin Clot Lysis Time
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Aortic Diseases; Coronary Artery Disease; Coronary Disease; Inflammation; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Coronary Aneurysm
• Other Study ID Numbers: 2020/39/NZ5/02863

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No