NCT04527367

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
14.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 21, 2022

Status Verified

December 1, 2021

Enrollment Period

16 years

First QC Date

August 22, 2020

Last Update Submit

January 6, 2022

Conditions

Valvular DiseaseValvular Heart DiseaseAortic Valve StenosisMitral Insufficiency and Aortic StenosisMitral StenosisCoronary Artery DiseaseChronic Kidney Diseases

Keywords

Valvular Heart DiseaseAortic Valve StenosisMitral InsufficiencyCoronary Artery DiseaseChronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • Death

    All-cause of mortality

    3665 days

Secondary Outcomes (1)

  • MACCE

    3665 days

Study Arms (1)

VHD patients

Patients with moderate and severe valvular heart diseases

Procedure: Innovative medical technologies in invasive cardiology and cardiac surgery

Interventions

Innovative medical technologies in invasive cardiology and cardiac surgeryPROCEDURE

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.

Also known as: Percutaneous coronary intervention, Percutaneous aortic valve replacement, Percutaneous interventional mitral regurgitation treatment, Cardiosurgery
VHD patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in Medical University of Bialystok.

You may qualify if:

  • Valvular heart disease in moderate and severe stages

You may not qualify if:

  • Age \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital

Bialystok, 15-276, Poland

Location

Related Publications (2)

  • Kuzma L, Bachorzewska-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). Postepy Kardiol Interwencyjnej. 2019;15(4):422-430. doi: 10.5114/aic.2019.90216. Epub 2019 Dec 8.

    PMID: 31933658RESULT

  • Kuzma L, Malyszko J, Bachorzewska-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: 10.1007/s11255-020-02561-4. Epub 2020 Jul 14.

    PMID: 32661631RESULT

MeSH Terms

Conditions

Heart Valve DiseasesAortic Valve StenosisMitral Valve InsufficiencyMitral Valve StenosisCoronary Artery DiseaseRenal Insufficiency, Chronic

Interventions

Cardiac Surgical ProceduresPercutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesAortic Valve DiseaseVentricular Outflow ObstructionCoronary DiseaseMyocardial IschemiaArteriosclerosisArterial Occlusive DiseasesVascular DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical ProceduresEndovascular ProceduresVascular Surgical ProceduresMinimally Invasive Surgical Procedures

Study Officials

  • Łukasz Kuźma, MD, PhD

    Medical University of Bialystok

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator,

Study Record Dates

First Submitted

August 22, 2020

First Posted

August 26, 2020

Study Start

January 1, 2006

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

January 21, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)