The Impact of Frailty on Thrombosis of Elderly Patients With NVAF （FTE-NVAF）

July 15, 2020 updated by: Hongwei Li, MD, Beijing Friendship Hospital

The Impact of Frailty on Thrombosis of Elderly Patients With Non-valvular Atrial Fibrillation (NVAF).

This study aims to investigate the use of anticoagulants in elderly patients with non-valvular atrial fibrillation (NVAF) and the incidence of frailty in elderly patients with NVAF. After two years follow-up, we observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The inhospital patients (≥65yr) with NVAF of Beijing Friendship Hospital, Capital Medical University

Description

Inclusion Criteria:

  • ≥65yr
  • Confirmed non-valvular atrial fibrillation (NVAF) diagnosis with ECG or Holter
  • fulfilled CHA2DS2-VASc, HAS-BLED and Fried Scale
  • patients agreed and provided informed consent

Exclusion Criteria:

  • valvular atrial fibrillation
  • cardiac surgery related atrial fibrillation
  • acute disease related atrial fibrillation
  • patients not fulfilled all the exam and text，or not accept the follow-up

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
Participates
This is an observational study
Other: Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale.
This is an observational study. All the patients evaluate with CHA2DS2-VASc, HAS-BLED and Fried Scale, and observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic stroke
Time Frame: 24 months
Cerebral infarction, Transient ischemic attack, Cerebral embolism.
24 months
Massive hemorrhage
Time Frame: 24 months
Life-threatening or imminently fatal bleeding, intracranial, retroperitoneal, compartment syndrome, massive gastrointestinal, etc.
24 months
All-cause death
Time Frame: 24 months
All-cause death during the 2-year observation
24 months

Collaborators and Investigators

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

Sponsor

Beijing Friendship Hospital

Investigators

  • Principal Investigator: Yunli Xing, Dr., Beijing Friendship Hospital

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 (Anticipated)

August 1, 2020

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 17, 2020

Study Record Updates

Last Update Posted (Actual)

July 17, 2020

Last Update Submitted That Met QC Criteria

July 15, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BFH - Frailty and thrombosis

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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