CClinicalTrials.gg
Sign In
Status unknownNCT03413345Updated Jan 29, 2018

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

An observational study in Cardiovascular Diseases, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Status unknown at 1 site in Italy. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-01-29.

Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational

The sponsor has not verified this record recently (last verified Nov 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
1
Ages
18 Years to 85 Years
Sex
All
01

Study 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

02

Conditions studied

  • Cardiovascular Diseases
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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)

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

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
04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
1 participant (estimated)
Patient registry
No

Groups and cohorts

  • subjects without a history of cardiac disease
  • subjects with a history of cardiac disease
05

What researchers measure

Primary outcomes

  1. Effect of rehabilitation on the ejection fraction (FE) in cardiopathic and non-cardiac patients undergoing major orthopedic surgery

    Left ventricular evaluation of ejection fraction (FE) at 6 months in cardiopathic patients with vitamin D deficiency subjected to supplementation with calcifediol

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • IRCCS Istituto Ortopedico Galeazzi
    Milan, 20161, Italy
    Recruiting
07

Registry details

Key details

Study ID
NCT03413345
Lead sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible party
Sponsor
First posted
Jan 29, 2018
Start date
Sep 23, 2015
Primary completion
Sep 23, 2015
Completion
Jan 18, 2019 (estimated)
Last update
Jan 29, 2018

Study contacts

Maurizio Turiel
Contact
maurizio.turiel@unimi.it
0266214945

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Cardiovascular Diseases→

Other studies from this sponsor

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

Start the discussion