Cardiovascular Diseases Clinical Trial
Official title:
Effect of Rehabilitation on Ejection Fraction (FE) in Cardiopathic and Non Cardiopathic Patients Undergoing Major Orthopedic Surgery
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
| Status | Recruiting |
| Enrollment | 1 |
| Est. completion date | January 18, 2019 |
| Est. primary completion date | September 23, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | IRCCS Istituto Ortopedico Galeazzi | Milan |
| Lead Sponsor | Collaborator |
|---|---|
| Istituto Ortopedico Galeazzi |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |
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