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

January 26, 2018 updated by: Istituto Ortopedico Galeazzi
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

Study Overview

Status

Unknown

Study Type

Observational

Enrollment (Anticipated)

1

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 Locations

      • Milan, Italy, 20161
        • Recruiting
        • IRCCS Istituto Ortopedico Galeazzi
        • Contact:

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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

the population consists of 188 subjects (94 subjects for the cardiopathic arm and 94 subjects for the non-cardiopathic arm) undergoing to major orthopedic surgery (hip and knee prosthesis)

Description

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

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
subjects without a history of cardiac disease
subjects with a history of cardiac disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of rehabilitation on the ejection fraction (FE) in cardiopathic and non-cardiac patients undergoing major orthopedic surgery
Time Frame: 6 months
Left ventricular evaluation of ejection fraction (FE) at 6 months in cardiopathic patients with vitamin D deficiency subjected to supplementation with calcifediol
6 months

Collaborators and Investigators

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

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)

September 23, 2015

Primary Completion (ACTUAL)

September 23, 2015

Study Completion (ANTICIPATED)

January 18, 2019

Study Registration Dates

First Submitted

December 19, 2017

First Submitted That Met QC Criteria

January 26, 2018

First Posted (ACTUAL)

January 29, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 29, 2018

Last Update Submitted That Met QC Criteria

January 26, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Epiq7CC2013

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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