Optimization of Management in Patients With Cardiovascular Disease After Lower Limb Joint Replacement

May 11, 2026 updated by: Olga Trushina, I.M. Sechenov First Moscow State Medical University
The goal of the study is to evaluate the frequency of cardiovascular and thromboembolic complications in patients with cardiovascular disease after lower limb joint replacement, the influence of known risk factors and strategies for perioperative prevention of thromboembolic complications on the frequency of cardiovascular complications and to develop approaches to optimize antithrombotic prevention tactics.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1733

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

  • Russia
      • Moscow, Russia, 119991
        • University hospital #1

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study is planned to include 1,000 patients with cardiovascular diseases who undergo routine endoprosthetics of large joints of the lower extremities. During the follow-up, patients will be divided into subgroups depending on the scheme of perioperative prevention of thromboembolic complications and the presence of risk factors. The comparison will be carried out in the appropriate subgroups.

Description

Inclusion Criteria:

  • Informed consent
  • Age older than 18 y.o.
  • Cardiovascular disease
  • Indications for planned lower limb joint replacement surgery

Exclusion Criteria:

  • Pregnancy
  • Psychiatric disorders
  • Decompensated heart failure or acute heart failure
  • Known diagnosis of cancer

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Low thromboembolic risk
Moderate thromboembolic risk
High thromboembolic risk
Other: No intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bleeding
Time Frame: 1 month
All the cases of major and minor bleeding within 1 month
1 month
Bleeding
Time Frame: 3 months
All the cases of major and minor bleeding within 3 months
3 months
Bleeding
Time Frame: 6 months
All the cases of major and minor bleeding within 6 months
6 months
Thromboembolism
Time Frame: 1 month
All the cases of venous thromboembolism within 1 month
1 month
Thromboembolism
Time Frame: 3 months
All the cases of venous thromboembolism within 3 months
3 months
Thromboembolism
Time Frame: 6 months
All the cases of venous thromboembolism within 6 months
6 months

Collaborators and Investigators

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

Sponsor

I.M. Sechenov First Moscow State Medical University

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 15, 2023

Primary Completion (Actual)

January 15, 2025

Study Completion (Estimated)

September 10, 2027

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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