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

NCT ID: NCT04476147

Last Updated: 2020-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2024-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Non-valvular Atrial Fibrillation, Elderly, Frailty, Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participates

This is an observational study

Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale.

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hongwei Li, MD

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yunli Xing, Dr.

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongwei Li, Prof.

Role: CONTACT

0086 10 63139780

Yunli Xing, Dr.

Role: CONTACT

0086 10 63139595

Facility Contacts

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Hongwei Li

Role: primary

0086 10 63139780

Xuhe Gong

Role: backup

0086 10 63139780

References

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Xing Y, Ma Q, Ma X, Wang C, Zhang D, Sun Y. CHADS2 score has a better predictive value than CHA2DS2-VASc score in elderly patients with atrial fibrillation. Clin Interv Aging. 2016 Jul 14;11:941-6. doi: 10.2147/CIA.S105360. eCollection 2016.

Reference Type BACKGROUND
PMID: 27478371 (View on PubMed)

Xing YL, Ma Q, Ma XY, Wang CY, Zhou Z, Huang YS, Sun Y. Characteristics of non-valvular atrial fibrillation patients who benefit most from anticoagulation treatment. Int J Clin Exp Med. 2015 Oct 15;8(10):18721-8. eCollection 2015.

Reference Type BACKGROUND
PMID: 26770487 (View on PubMed)

Fumagalli S, Said SAM, Laroche C, Gabbai D, Marchionni N, Boriani G, Maggioni AP, Popescu MI, Rasmussen LH, Crijns HJGM, Lip GYH; EORP-AF Investigators. Age-Related Differences in Presentation, Treatment, and Outcome of Patients With Atrial Fibrillation in Europe: The EORP-AF General Pilot Registry (EURObservational Research Programme-Atrial Fibrillation). JACC Clin Electrophysiol. 2015 Aug;1(4):326-334. doi: 10.1016/j.jacep.2015.02.019. Epub 2015 Apr 20.

Reference Type BACKGROUND
PMID: 29759321 (View on PubMed)

Bo M, Li Puma F, Badinella Martini M, Falcone Y, Iacovino M, Grisoglio E, Bonetto M, Isaia G, Ciccone G, Isaia GC, Gaita F. Health status, geriatric syndromes and prescription of oral anticoagulant therapy in elderly medical in-patients with atrial fibrillation: a prospective observational study. Int J Cardiol. 2015;187:123-5. doi: 10.1016/j.ijcard.2015.03.334. Epub 2015 Mar 21. No abstract available.

Reference Type BACKGROUND
PMID: 25828331 (View on PubMed)

Mazzone A, Bo M, Lucenti A, Galimberti S, Bellelli G, Annoni G. The role of comprehensive geriatric assessment and functional status in evaluating the patterns of antithrombotic use among older people with atrial fibrillation. Arch Gerontol Geriatr. 2016 Jul-Aug;65:248-54. doi: 10.1016/j.archger.2016.04.008. Epub 2016 Apr 13.

Reference Type BACKGROUND
PMID: 27131228 (View on PubMed)

Other Identifiers

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BFH - Frailty and thrombosis

Identifier Type: -

Identifier Source: org_study_id

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