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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04527367
Other study ID # UMB-KKI-101
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2006
Est. completion date January 2022

Study information

Verified date December 2021
Source Medical University of Bialystok
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. The aim of the study is analysis the epidemiology and the long-term prognosis among patients with VHD.


Description:

Valvular heart diseases are significant problem in Polish population. Coexistence of coronary artery disease in patients with VHD increases the risk of death and affects further therapeutic strategy. Patients with moderate and severe valvular heart diseases are included into the study. The set of variables subject to interpretation consisted of demographic data, medical history, result of coronary angiography, and type of applied percutaneous and surgical treatment


Recruitment information / eligibility

Status Completed
Enrollment 2500
Est. completion date January 2022
Est. primary completion date January 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Valvular heart disease in moderate and severe stages Exclusion Criteria: - Age < 18 years old

Study Design


Intervention

Procedure:
Innovative medical technologies in invasive cardiology and cardiac surgery
A follow-up study included the analysis of medical documentation of the Cardiosurgery and the Invasive Cardiology Departments to provided information on the duration and type of procedure performed.

Locations

Country Name City State
Poland Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital Bialystok

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Bialystok

Country where clinical trial is conducted

Poland, 

References & Publications (2)

Kuzma L, Bachórzewska-Gajewska H, Kozuch M, Struniawski K, Pogorzelski S, Hirnle T, Dobrzycki S. Acute coronary syndromes and atherosclerotic plaque burden distribution in coronary arteries among patients with valvular heart disease (BIA-WAD registry). Po — View Citation

Kuzma L, Malyszko J, Bachórzewska-Gajewska H, Niwinska MM, Kurasz A, Zalewska-Adamiec M, Kozuch M, Dobrzycki S. Impact of chronic kidney disease on long-term outcome of patients with valvular heart defects. Int Urol Nephrol. 2020 Nov;52(11):2161-2170. doi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Death All-cause of mortality 3665 days
Secondary MACCE Mocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization 3665 days
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