Major Adverse Cardiac EventsNCT05362266
Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization
An observational study of Major Adverse Cardiac Events and Adverse Effect of Unspecified General Anesthetic, run by Mahidol University at 2 sites in Thailand.
Trial summary
Acute limb ischemia is one of the devastating vascular emergencies that lead to life and limb loss if the appropriate treatment is not reached.The revascularization is a cornerstone in treating acute limb ischemia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Major Adverse Cardiac Events, Adverse Effect of Unspecified General Anesthetic
- How many people
- 240 participants
- Where
- 2 sitesThailand
- Study dates
- 10 Apr 2022to 1 Apr 2023
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Age more than 18, with acute limb ischemia undergoing revascularization procedure
Who may be able to join
- age more than 18 years
- undergoing revascularization surgery or procedure (surgical revascularization, endovascular revascularization, hybrid revascularization, catheter directed thrombolysis)
Who cannot join
- incomplete data during perioperative period
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Anesthesiology department, Siriraj Hospital, Mahidol University
Bangkok
MahidolU
Bangkok
About this study
Official title: Incidence and Risk Factors of in Hospital Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization Treatment: a Retrospective Cohort Study
Acute limb ischemia is one of the devastating vascular emergencies that lead to life and limb loss if the appropriate treatment is not reached.The revascularization is a cornerstone in treating acute limb ischemia. The conventional surgical approach includes surgical embolectomy and surgical bypass.From the anesthetic aspect, this emergency condition limits the lengthening cardiovascular assessment of this high-risk patient group which might lead to the uncertainty outcome.With the variety of patients and procedures, we sought to find out the perioperative adverse events, especially major adverse cardiac events, in acute ischemic limb patients undergoing revascularization, in order to increase awareness of the team and properly admit to ICU in a retrospective manner.
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiac events
Incidence of major adverse cardiac events, which are cardiovascular death, myocardial infarction, stroke
Measured: during hospital stay, up to 4 weeks
Secondary outcomes (2)
Incidence of the perioperative complication
Incidence of the perioperative other complication, which are major bleeding, repercussion syndrome, compartment syndrome, rhabdomyolysis and unplanned ICU admission from any causes.
Measured: during hospital stay, up to 4 weeks
Factors contribute to the adverse outcome
Factors contribute to the adverse outcome, which are the patients' condition and the underlying diseases, the surgical intervention and the anesthetic technique.
Measured: during hospital stay, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start10 Apr 2022
- Primary completion1 Mar 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Adverse Cardiac EventsStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05362266
- Sponsor's protocol ID
- 052/2565
- Status last verified
- Apr 2022
- First submitted
- 11 Apr 2022
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data has no plan for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Risk Factors of in Hospital Adverse Events in Acute Limb Ischemic Patient Undergoing Revascularization Treatment: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05362266
- Acronym / sponsor ID
- 052/2565
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 5 May 2022 (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.
Acute limb ischemia is one of the devastating vascular emergencies that lead to life and limb loss if the appropriate treatment is not reached.The revascularization is a cornerstone in treating acute limb ischemia. The conventional surgical approach includes surgical embolectomy and surgical bypass.From the anesthetic aspect, this emergency condition limits the lengthening cardiovascular assessment of this high-risk patient group which might lead to the uncertainty outcome.With the variety of patients and procedures, we sought to find out the perioperative adverse events, especially major adverse cardiac events, in acute ischemic limb patients undergoing revascularization, in order to increase awareness of the team and properly admit to ICU in a retrospective manner.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Age more than 18, with acute limb ischemia undergoing revascularization procedure
Key inclusion criteria (2 listed)
- age more than 18 years
- undergoing revascularization surgery or procedure (surgical revascularization, endovascular revascularization, hybrid revascularization, catheter directed thrombolysis)
Key exclusion criteria (1 listed)
- incomplete data during perioperative period
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
Incidence of major adverse cardiac events
Time frame: during hospital stay, up to 4 weeks
Incidence of major adverse cardiac events, which are cardiovascular death, myocardial infarction, stroke
2 secondary outcomes
Incidence of the perioperative complication
Time frame: during hospital stay, up to 4 weeks
Factors contribute to the adverse outcome
Time frame: during hospital stay, up to 4 weeks
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 14 Oct 2026.
- Individual participant dataSharing planned: No. The data has no plan for sharing.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Adverse Cardiac Events and Adverse Effect of Unspecified General Anesthetic, run by Mahidol University at 2 sites in Thailand.
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 2 inclusion and 1 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 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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?
Incidence of major adverse cardiac events (time frame: during hospital stay, up to 4 weeks). 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 14 Oct 2026.