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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03413345
Recruitment Status : Unknown
Verified November 2017 by Istituto Ortopedico Galeazzi.
Recruitment status was:  Recruiting
First Posted : January 29, 2018
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Brief Summary:
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

Condition or disease
Cardiovascular Diseases

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Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Rehabilitation on Ejection Fraction (FE) in Cardiopathic and Non Cardiopathic Patients Undergoing Major Orthopedic Surgery
Actual Study Start Date : September 23, 2015
Actual Primary Completion Date : September 23, 2015
Estimated Study Completion Date : January 18, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort
subjects without a history of cardiac disease
subjects with a history of cardiac disease



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03413345


Contacts
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Contact: Maurizio Turiel 0266214945 maurizio.turiel@unimi.it

Locations
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Italy
IRCCS Istituto Ortopedico Galeazzi Recruiting
Milan, Italy, 20161
Contact: Maurizio Turiel    0266214945    maurizio.turiel@unimi.it   
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
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Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03413345    
Other Study ID Numbers: Epiq7CC2013
First Posted: January 29, 2018    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: November 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases