Effect of Rehabilitation on Ejection Fraction (FE) in Cardiopathic and Non Cardiopathic Patients Undergoing Major Orthopedic Surgery

NCT ID: NCT03413345

Last Updated: 2018-01-29

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

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-23

Study Completion Date

2019-01-18

Brief Summary

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It is a trial aimed to evaluate the ejection fraction in the preoperative phase and during follow-up in two groups of subjects undergoing major orthopedic surgery: the first consisting of subjects without history of cardiac disease, and the second from subjects with a history of cardiopulmonary disease

Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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subjects without a history of cardiac disease

No interventions assigned to this group

subjects with a history of cardiac disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age: \< or equal 18 and \> or equal 85 years
* major orthopedic surgery
* rehabilitation at our site
* a positive history for the cardiopathic group

Exclusion Criteria

* Age: \> 85 and \< 18
* impossibility to participate to the rehabilitative protocol or come to the follow up visit
* lack of consensus
* previous acute cerebrovascular and / or cardiological events within 6 months prior to enrollment
* previous myocardial (percutaneous and / or surgical) revascularization interventions within the 6 months prior to enrollment
* previous (even in pediatric age) interventions of surgical correction of congenital heart disease
* severe heart failure
* reimplantation of prosthesis
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Maurizio Turiel

Role: CONTACT

0266214945

Facility Contacts

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Maurizio Turiel

Role: primary

0266214945

Other Identifiers

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Epiq7CC2013

Identifier Type: -

Identifier Source: org_study_id

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