Cardiovascular ComplicationNCT05116280
MACE and PE in Elective Primary TKA & THA
An observational study of Cardiovascular Complication and Pulmonary Embolism, run by University of Thessaly at 1 site in Greece.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Complication, Pulmonary Embolism, Stroke
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jan 2018to 30 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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. Operations were performed by the 4 chief arthroplasty surgeons of the department.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Registration of the Major Adverse Cardiovascular Events and Pulmonary Embolism in Primary Total Joint Arthroplasty
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
Read the detailed 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
- Keywords
- total joint arthroplasty, total hip arthroplasty, total knee arthroplasty, major adverse cardiovascular events, pulmonary embolism
- Medical subject headings
- Pulmonary Embolism, Stroke, Ischemic Attack, Transient, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TJA | patients with primary osteoarthritis of the knee and hip who underwent elective primary total hip and total knee arthroplasty. MACE and pulmonary embolism were recorded |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
MACE (non-fatal-cardiac arrest, acute myocardial infraction, congestive cardiac failure, cardiac arrhythmia, angina, stroke, cardiovascular death, cerebrovascular, death)
Measured: 1month postoperatively
Pulmonary Embolism
PE
Measured: 1month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start1 Jan 2018
- Primary completion31 Dec 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular ComplicationStudies of the same condition, open and under way.
- More trials run by University of ThessalyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Arnaoutoglou, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116280
- Sponsor's protocol ID
- MACE & PE in TJA
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registration of the Major Adverse Cardiovascular Events and Pulmonary Embolism in Primary Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT05116280
- Acronym / sponsor ID
- MACE & PE in TJA
- Keywords
- total joint arthroplasty, total hip arthroplasty, total knee arthroplasty, major adverse cardiovascular events, pulmonary embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TJA | – | –patients with primary osteoarthritis of the knee and hip who underwent elective primary total hip and total knee arthroplasty. MACE and pulmonary embolism were recorded |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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. Operations were performed by the 4 chief arthroplasty surgeons of the department.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 1month postoperatively
MACE (non-fatal-cardiac arrest, acute myocardial infraction, congestive cardiac failure, cardiac arrhythmia, angina, stroke, cardiovascular death, cerebrovascular, death)
Pulmonary Embolism
Time frame: 1month postoperatively
PE
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Complication and Pulmonary Embolism, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (time frame: 1month postoperatively). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2021.