Coronary Artery Ectasia Database - Poland

NCT06057987 | Unknown

• 1 other identifier: 687/23
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Aneurysm; Coronary Artery Ectasia

Outcome Measures

Primary Outcomes (3)

• Incidence of CAAE

  Incidence of CAAE in the Polish population based on coronary angiography

  12 months

• All-cause death

  6 months

• Re-hospitalization

  Re-hospitalization for unstable angina, myocardial infarction, heart failure, bleeding, stroke, embolic events

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be included ambispectively based on the angiographic diagnosis of CAA or CAE. CAA is defined as a focal dilatation with a diameter of more than or equal to 1.5 times the adjacent normal coronary segment, while CAE is analogous lesions but more diffuse, exceeding more than a third of the coronary artery length. A giant CAAE is diagnosed when the diameter of the artery exceeded 4-fold the diameter of the reference vessel. Each participating center with the cath lab will enroll patients retrospectively from their internal databases after evaluation of coronary angiography by an experienced interventional cardiologist using quantitative coronary angiography (QCA), but also prospectively for 6 months from the CARED-POL joining. The patient data will be collected from standardized and anonymous forms via Scientific Platform of the Polish Society of Cardiology. In accordance with initial assumptions 2,000 patients in all participating centers will be included.

You may qualify if:

• 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

You may not qualify if:

• the lack of informed consent for prospectively enrolled patients

Sponsors & Collaborators

• Poznan University of Medical Sciences: lead

Study Sites (1)

Poznan University of Medical Sciences, Poland

Poznan, Wielkopolska, 61-701, Poland

RECRUITING

MeSH Terms

Conditions

Coronary Aneurysm

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Aneurysm; Vascular Diseases

Study Officials

• Sylwia Iwańczyk, MD, PhD

  Poznań University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylwia Iwańczyk, MD, PhD

CONTACT

+48 61-854-91-46; siwanczyk@ump.edu.pl

Konrad Stępień, MD, PhD

CONTACT

+48 61-854-91-46; konste@interia.pl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: July 14, 2023
• Primary Completion: July 14, 2024
• Study Completion: August 1, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Locations

PL (1)