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Coronary Artery Ectasia Database - Poland

Polish Registry of Coronary Artery Aneurysms and Ectasias. Coronary ARtery Ectasia Database - Poland (CARED-POL).

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06057987
Acronym
CARED-POL
Enrollment
2000
Registered
2023-09-28
Start date
2023-07-14
Completion date
2024-08-31
Last updated
2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Aneurysm, Coronary Artery Ectasia

Brief summary

The goal of this observational study is to comprehensively investigate the current prevalence, morphological characteristics, risk factors for the development, complications as well as long-term prognosis of coronary artery aneurysm and ectasia (CAAE) in the Polish population. Data obtained from the CARED-POL Registry will enable the selection of morphological risk factors for the unfavorable course of CAAE, including the progression and development of giant aneurysms, aneurysm clotting with vessel occlusion, and thromboembolic complications. Comparing the safety and effectiveness of available CAAE treatment methods in individual patient subgroups will allow individualization of treatment, including anticoagulant therapy.

Detailed description

Coronary artery aneurysm or ectasia (CAAE) is a rare vascular pathology diagnosed in 0.15-5.3% of patients undergoing coronary angiography. CAAEs are often diagnosed incidentally, while symptomatic patients experience various complications, including unstable angina, acute myocardial infarction, arrhythmias, or sudden cardiac death. The most common etiology of CAAE is atherosclerosis, Kawasaki disease, or other vasculitis. Detailed pathomechanisms and risk factors of unfavorable courses of CAAE have not yet been known. In addition, the data on Polish patients are limited to case reports, case series, and small groups from major academic centers. CARED-POL is a multicenter, observational nationwide registry of CAAE. Patients will be included ambispectively based on the angiographic diagnosis of coronary artery aneurysm (CAA) or coronary artery ectasia (CAE). All participating centers will enroll patients retrospectively based on their internal databases after evaluation of coronary angiography by an experienced interventional cardiologist and prospectively for six months from the CARED-POL joining. Angiographic assessment will be based on quantitative coronary angiography (QCA). The patient data will be collected from standardized and anonymous forms via the Scientific Platform of the Polish Society of Cardiology. In accordance with initial assumptions, 2,000 patients in all participating centers will be included. Patients included in the registry will undergo a minimum of 6 months of follow-up with assessment of the following endpoints: all-cause death, re-hospitalization for unstable angina, myocardial infarction, heart failure, bleeding, stroke, embolic events, and any cause for repeat coronary angiography. Data will be obtained from outpatient visits, medical records, or telephone interviews. In patients who undergo repeated coronary angiography, the formation of a new aneurysm or progression of an existing one will be detected. Aneurysm progression is diagnosed as an increase in size demonstrated on at least two orthogonal angiographic views.

Interventions

None listed

Sponsors

Poznan University of Medical Sciences
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* CAA or CAE defined as a focal dilatation with a diameter of more than or equal to 1.5 times the adjacent normal coronary segment

Exclusion criteria

* the lack of informed consent for prospectively enrolled patients

Design outcomes

Primary

MeasureTime frameDescription
Incidence of CAAE12 monthsIncidence of CAAE in the Polish population based on coronary angiography
All-cause death6 months
Re-hospitalization6 monthsRe-hospitalization for unstable angina, myocardial infarction, heart failure, bleeding, stroke, embolic events

Countries

Poland

Contacts

Primary ContactSylwia Iwańczyk, MD, PhD
siwanczyk@ump.edu.pl+48 61-854-91-46
Backup ContactKonrad Stępień, MD, PhD
konste@interia.pl+48 61-854-91-46

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026