NCT03413345

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 19, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2019

Completed
Last Updated

January 29, 2018

Status Verified

November 1, 2017

Enrollment Period

Same day

First QC Date

December 19, 2017

Last Update Submit

January 26, 2018

Conditions

Cardiovascular Diseases

Outcome Measures

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

    6 months

Study Arms (2)

subjects without a history of cardiac disease

subjects with a history of cardiac disease

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Maurizio Turiel

CONTACT

0266214945maurizio.turiel@unimi.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2017

First Posted

January 29, 2018

Study Start

September 23, 2015

Primary Completion

September 23, 2015

Study Completion

January 18, 2019

Last Updated

January 29, 2018

Record last verified: 2017-11

Locations

IT(1)