Assessment of Frailty as a Risk Factor for Cardiac and Vascular Surgery

NCT ID: NCT02224222

Last Updated: 2019-04-09

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

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2020-07-31

Brief Summary

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The purpose of this study is to assess the impact of frailty as a multidimensional risk factor on the outcomes of adult cardiac and vascular surgery. For the purpose of defining patient frailty a multimodal questionnaire has been developed including measurement of psychological, socioeconomical, neurological and behavioral aspects. This study also features an investigation of the possible relationship between sudden regional weather changes, individual meteorological susceptibility of the patients and the outcomes of adult cardiac and vascular surgery.

Detailed Description

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Conditions

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Intellectual Frailty of Aging Cardiovascular Diseases Myocardial Infarction Vascular Diseases Heart; Dysfunction Postoperative, Cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing vascular procedures

Including all non-interventional surgical procedures, excluding varix surgery

No interventions assigned to this group

Patients undergoing cardiac procedures

Including all non-interventional surgical procedures, excluding HTX

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients, 18 years or older, admitted to the hospital for elective cardiac or vascular surgery.

Exclusion Criteria

* Not willing to participate.
* Pregnant women.
* During active psychiatric hospital care.
* Patients with defined legal incapability or limited capability.
* Congenital or acquired speech impediment and locomotion disability of any kind.
* Non-evaluable patient due to communication problems and insufficient clinical information for the judgement of frailty (CFS).
* Patients admitted solely for elective surgery of the varices of the lower extremities.
* Patients with a transplanted heart.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Semmelweis University Heart and Vascular Center

OTHER

Sponsor Role lead

Responsible Party

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Andrea Szekely

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrea Székely, MD, PhD

Role: STUDY_DIRECTOR

Semmelweis University, Department of Anesthesiology and Intensive Therapy

Daniel J Lex, MD

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University Heart and Vascular Center

Nikoletta Czobor

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Peter Misnyovszki

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Hanna Tihanyi

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Kalatin Fink, MD

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Béla Merkely, MD, PhD, DSc

Role: STUDY_CHAIR

Semmelweis University

László Entz, MD, PhD

Role: STUDY_CHAIR

Semmelweis University

Zoltán Szabolcs, MD, PhD

Role: STUDY_CHAIR

Semmelweis University

János Gál, MD, PhD

Role: STUDY_CHAIR

Semmelweis University

Erzsébet Paulovich, MD

Role: STUDY_CHAIR

Semmelweis University

Eniko Holndonner-Kirst, MD

Role: PRINCIPAL_INVESTIGATOR

Semmelweis University

Locations

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Semmelweis University, Heart and Vascular Center

Budapest, , Hungary

Site Status

Countries

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Hungary

References

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Toth K, Szabo A, Nagy A, Szabo D, Szecsi B, Eke C, Sandor A, Susanszky E, Holndonner-Kirst E, Merkely B, Gal J, Szekely A. Preoperative nutritional state is associated with mid- and long-term mortality after cardiac surgery. Ann Palliat Med. 2021 Nov;10(11):11333-11347. doi: 10.21037/apm-21-1015. Epub 2021 Sep 29.

Reference Type DERIVED
PMID: 34670385 (View on PubMed)

Szabo A, Toth K, Nagy A, Domokos D, Czobor N, Eke C, Sandor A, Merkely B, Susanszky E, Gal J, Szekely A. The effect of cognitive dysfunction on mid- and long-term mortality after vascular surgery. BMC Geriatr. 2021 Jan 13;21(1):46. doi: 10.1186/s12877-020-01994-x.

Reference Type DERIVED
PMID: 33441102 (View on PubMed)

Other Identifiers

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VSZÉK-FRAILTY

Identifier Type: -

Identifier Source: org_study_id

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