Coronary Artery AneurysmCARE-ANUERYSMNCT05183373
Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease
An observational study of Coronary Artery Aneurysm and Abdominal Aortic Aneurysm, run by John Paul II Hospital, Krakow at 1 site in Poland.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Aneurysm, Abdominal Aortic Aneurysm, Coronary Disease
- What is being tested?
- Evaluation of inflammation and clotting
- How many people
- 180 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jan 2022to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-comer, consecutive patients with the contiontds under the evaluation in this study will be screen for enrolment.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Cardiac and Vascular Diseases, John Paul II Hospital
Krakow, 31-202
Piotr Musialek, MD, DPhil, +48126142287, pmusialek@szpitaljp2.krakow.pl
About this study
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.
- Being tested
- Evaluation of inflammation and clotting
- Keywords
- Coronary Artery Aneurysm, Inflammation, Fibrin Clot Lysis Time, Coronary Disease, Abdominal Aortic Aneurysm
- Medical subject headings
- Coronary Aneurysm, Aortic Aneurysm, Abdominal, Coronary Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of inflammation and clottingOther
Evaluation of inflammation biomarkers (such as 8-isoprostane, Il-6) and fibrin clot properties (such as clot lysis time, clot permeability)
| Study group | Role | What they receive |
|---|---|---|
| Aneurysmal coronary artery disease | Patients with coronary artery ectasia or/and aneurysm diagnosed during coronary angiography Receives: Other: Evaluation of inflammation and clotting | |
| Abdominal aortic aneurysm | Patients with diagnosed with abdominal aortic aneurysm Receives: Other: Evaluation of inflammation and clotting | |
| Coronary artery disease | Patients with diagnosed with coronary artery disease Receives: Other: Evaluation of inflammation and clotting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation
Level of inflammation biomarkers (such as 8-isoprostane, Il-6) in each group
Measured: Baseline (at enrolment)
Clotting
Fibrin clot properties (such as clot lysis time, clot permeability) in each group
Measured: Baseline (at enrolment)
Composite Clinical outcome after 1 year
Death, stroke, myocardial infarction
Measured: 1 year after the enrolment
Composite Clinical outcome after 5 years
Death, stroke, myocardial infarction
Measured: 5 years after the enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2022
- Study start10 Jan 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Paul II Hospital, Krakow
- Sponsor type
- University, hospital or other
- Collaborators
- Jagiellonian University, National Science Centre, Poland
- Responsible party
- Sponsor
- Investigators
- Piotr Musiałek, MD, DPhil, Principal investigator, John Paul II Hospital, Krakow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05183373
- Sponsor's protocol ID
- 2020/39/NZ5/02863
- Acronym
- CARE-ANUERYSM
- Status last verified
- Jan 2022
- First submitted
- 5 Jan 2022
- Last updated
- 10 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 29051141Kawsara 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 29976357Gunasekaran 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 30393992Boles 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 29337902Brunetti 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 24553454Chmiel J, Kopytek M, Dabrowski M, Iwanczyk S, Musial K, Wozniak P, Chmiel J, Partyka L, Zabczyk M, Natorska J, Musialek P. Fibrin Clot Properties in Aneurysmal Coronary Artery Disease: CARE-ANEURYSM Study. Int J Mol Sci. 2026 Oct 13;27(20):9059. doi: 10.3390/ijms27209059.
PubMed 42941832Chmiel 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.
PubMed 37660376
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Clotting Abnormalities in Aneurysmal Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT05183373
- Acronym / sponsor ID
- CARE-ANUERYSM / 2020/39/NZ5/02863
- Keywords
- Coronary Artery Aneurysm, Inflammation, Fibrin Clot Lysis Time, Coronary Disease, Abdominal Aortic Aneurysm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- John Paul II Hospital, KrakowUniversity, hospital or other
- Collaborators
- Jagiellonian University, National Science Centre, Poland
- Study start
- 10 Jan 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aneurysmal coronary artery disease | – | Other: Evaluation of inflammation and clottingPatients with coronary artery ectasia or/and aneurysm diagnosed during coronary angiography |
| Abdominal aortic aneurysm | – | Other: Evaluation of inflammation and clottingPatients with diagnosed with abdominal aortic aneurysm |
| Coronary artery disease | – | Other: Evaluation of inflammation and clottingPatients with diagnosed with coronary artery disease |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comer, consecutive patients with the contiontds under the evaluation in this study will be screen for enrolment.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- Less than 12 months from ACS
- Actual oral anticoagulant therapy
- Actual antiplatelet therapy other than aspirin
- Heart failure NYHA IV
- Untreated hyperthyroidism or hypothyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of inflammation and clottingEvaluation of inflammation biomarkers (such as 8-isoprostane, Il-6) and fibrin clot properties (such as clot lysis time, clot permeability) | Other | Abdominal aortic aneurysm, Aneurysmal coronary artery disease, Coronary artery disease |
Primary outcome
Inflammation
Time frame: Baseline (at enrolment)
Level of inflammation biomarkers (such as 8-isoprostane, Il-6) in each group
Clotting
Time frame: Baseline (at enrolment)
Fibrin clot properties (such as clot lysis time, clot permeability) in each group
Composite Clinical outcome after 1 year
Time frame: 1 year after the enrolment
Death, stroke, myocardial infarction
Composite Clinical outcome after 5 years
Time frame: 5 years after the enrolment
Death, stroke, myocardial infarction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Background: PubMed 29051141Doi 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.
- Background: PubMed 29976357Kawsara 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.
- Background: PubMed 30393992Gunasekaran 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.
- Background: PubMed 29337902Boles 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.
- Background: PubMed 24553454Brunetti 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.
- Derived from this study: PubMed 42941832Chmiel J, Kopytek M, Dabrowski M, Iwanczyk S, Musial K, Wozniak P, Chmiel J, Partyka L, Zabczyk M, Natorska J, Musialek P. Fibrin Clot Properties in Aneurysmal Coronary Artery Disease: CARE-ANEURYSM Study. Int J Mol Sci. 2026 Oct 13;27(20):9059. doi: 10.3390/ijms27209059.
- Derived from this study: PubMed 37660376Chmiel 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Musiałek, MD, DPhil principal investigator
John Paul II Hospital, Krakow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Aneurysm and Abdominal Aortic Aneurysm, run by John Paul II Hospital, Krakow at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Piotr Musiałek, MD DPhil (+48126143501, p.musialek@szpitaljp2.krakow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation (time frame: Baseline (at enrolment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05183373, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.