Epidemiology and Long-term Outcome of Patients With VHD (BIA-WAD)

January 6, 2022 updated by: Lukasz Kuzma, Medical University of Bialystok

Epidemiology and Long-term Prognosis of Patients With Valvular Heart Diseases (BIA-WAD Study)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Białystok, Poland, 15-276
        • Department of Invasive Cardiology, Medical University of Bialystok, The Medical University of Bialystok Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients hospitalized in Medical University of Bialystok.

Description

Inclusion Criteria:

  • Valvular heart disease in moderate and severe stages

Exclusion Criteria:

  • Age < 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
VHD patients
Patients with moderate and severe valvular heart diseases
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.
Other Names:
  • Percutaneous coronary intervention
  • Percutaneous aortic valve replacement
  • Percutaneous interventional mitral regurgitation treatment
  • Cardiosurgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: 3665 days
All-cause of mortality
3665 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACCE
Time Frame: 3665 days
Mocardial infarction, stent thrombosis, stroke or transient ischemic attack, urgent revascularization
3665 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Bialystok

Investigators

  • Principal Investigator: Łukasz Kuźma, MD, PhD, Medical University of Bialystok

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2006

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

January 1, 2022

Study Registration Dates

First Submitted

August 22, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 26, 2020

Study Record Updates

Last Update Posted (Actual)

January 21, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMB-KKI-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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