- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03413345
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
Conditions
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
- Name: Maurizio Turiel
- Phone Number: 0266214945
- Email: maurizio.turiel@unimi.it
Study Locations
-
-
-
Milan, Italy, 20161
- Recruiting
- IRCCS Istituto Ortopedico Galeazzi
-
Contact:
- Maurizio Turiel
- Phone Number: 0266214945
- Email: maurizio.turiel@unimi.it
-
-
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.
Sponsor
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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