Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06057987
Status:
RECRUITING
Last Update Posted:
2023-09-29
First Post:
2023-09-21
Brief Title:
Coronary Artery Ectasia Database - Poland
Sponsor:
Poznan University of Medical Sciences
Organization:
Poznan University of Medical Sciences
Study Overview
Official Title:
Polish Registry of Coronary Artery Aneurysms and Ectasias Coronary ARtery Ectasia Database - Poland CARED-POL
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CARED-POL
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
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 015-53 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 2000 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
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 2000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None