MACE and PE in Elective Primary TKA & THA

Stroke Clinical Trial

Official title:

Registration of the Major Adverse Cardiovascular Events and Pulmonary Embolism in Primary Total Joint Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05116280
• Other study ID #: MACE & PE in TJA
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: October 2021
• Source: University of Thessaly
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study ought to identify the occurence of the major adverse cardiovascular events (MACE) and the pumonary emoblism (PE) in patients undergoing elective primary THA & TKA

Description:

The study included 220 consecutive patients undergoing elective primary THA & TKA from January 2018 to December 2018. The occcurence of major adverse cardiovascular events (MACE) and the pumonary emoblism (PE) were recorder. Under the term MACE the following were included; non fatal cardiac arrest acute myocardial infraction congestive cardiac failure cardiac arrhythmia agnina stroke cardiovascular death cerebrovascular death

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All consecutive patients age 18 years or older, with a diagnosis of primary osteoarthritis of the hip or knee, who underwent elective, primary, unilateral TKA or THA.

Exclusion Criteria:

• previous TKA or THA within 3 months

• Revision surgery

• Surgical procedures related to a previous complication

• ASA PS IV

• recent history (6 months) of unstable acute coronary syndrome or decompensated heart failure

Related Conditions & MeSH terms

• Cardiovascular Complication
• Death
• Embolism
• Ischemic Attack, Transient
• Pulmonary Embolism
• Stroke
• Transient Ischemic Attack

Locations

Country	Name	City	State
Greece	University of Thessaly	Larissa

Sponsors (1)

Lead Sponsor	Collaborator
University of Thessaly

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Cardiovascular Events	MACE (non-fatal-cardiac arrest, acute myocardial infraction, congestive cardiac failure, cardiac arrhythmia, angina, stroke, cardiovascular death, cerebrovascular, death)	1month postoperatively
Primary	Pulmonary Embolism	PE	1month postoperatively