Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06057987 |
| Other study ID # |
687/23 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 14, 2023 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
September 2023 |
| Source |
Poznan University of Medical Sciences |
| Contact |
Sylwia Iwanczyk, MD, PhD |
| Phone |
+48 61-854-91-46 |
| Email |
siwanczyk[@]ump.edu.pl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
