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RecruitingNCT05183373CARE-ANUERYSMUpdated Jan 10, 2022

Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease

An observational study in Coronary Artery Aneurysm, Abdominal Aortic Aneurysm and Coronary Disease, sponsored by John Paul II Hospital, Krakow. Recruiting at 1 site in Poland. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-01-10.

Sponsored by John Paul II Hospital, Krakow · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
180
Ages
18 Years to 85 Years
Sex
All
01

Study 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).

Read the 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.

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Conditions studied

  • Coronary Artery Aneurysm
  • Abdominal Aortic Aneurysm
  • Coronary Disease

Keywords

  • Coronary Artery Aneurysm
  • Inflammation
  • Fibrin Clot Lysis Time
  • Coronary Disease
  • Abdominal Aortic Aneurysm
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
180 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Aneurysmal coronary artery disease

    Patients with coronary artery ectasia or/and aneurysm diagnosed during coronary angiography

    Other: Evaluation of inflammation and clotting

  • Abdominal aortic aneurysm

    Patients with diagnosed with abdominal aortic aneurysm

    Other: Evaluation of inflammation and clotting

  • Coronary artery disease

    Patients with diagnosed with coronary artery disease

    Other: Evaluation of inflammation and clotting

Interventions

  • OtherEvaluation 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)

05

What researchers measure

Primary outcomes

  1. Inflammation

    Level of inflammation biomarkers (such as 8-isoprostane, Il-6) in each group

    Time frame: Baseline (at enrolment)

  2. Clotting

    Fibrin clot properties (such as clot lysis time, clot permeability) in each group

    Time frame: Baseline (at enrolment)

  3. Composite Clinical outcome after 1 year

    Death, stroke, myocardial infarction

    Time frame: 1 year after the enrolment

  4. Composite Clinical outcome after 5 years

    Death, stroke, myocardial infarction

    Time frame: 5 years after the enrolment

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Study locations

1 of 1 sites recruiting
  • Department of Cardiac and Vascular Diseases, John Paul II Hospital
    Krakow, 31-202, Poland
    Recruiting
07

References and documents

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. PubMed 29051141 ↗
  • 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. PubMed 29976357 ↗
  • 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. PubMed 30393992 ↗
  • 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. PubMed 29337902 ↗
  • 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. PubMed 24553454 ↗

Individual participant data

Plan to share: Undecided

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Registry details

Key details

Study ID
NCT05183373
Lead sponsor
John Paul II Hospital, Krakow
Collaborators
Jagiellonian University, National Science Centre, Poland
Responsible party
Sponsor
First posted
Jan 10, 2022
Start date
Jan 10, 2022 (estimated)
Primary completion
Sep 30, 2024 (estimated)
Completion
Sep 30, 2025 (estimated)
Last update
Jan 10, 2022

Study contacts

Piotr Musiałek, MD DPhil
Contact
p.musialek@szpitaljp2.krakow.pl
+48126143501
Piotr Musiałek, MD, DPhil
principal investigator · John Paul II Hospital, Krakow

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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