Carotid StenosisNCT03596229
Major Adverse Cardiac Events After Carotid Endarterectomy
An observational study of Carotid Stenosis and Carotid Endarterectomy, run by Mahidol University at 1 site in Thailand.
Trial summary
Carotid endarterectomy is the operation for curing the significant carotid artery stenotic patients who are also at high cardiac risk. This retrospective study is to find out the incidence and risk factors related. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carotid Stenosis, Carotid Endarterectomy, Adverse Cardiac Events
- How many people
- 175 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2018to 15 Jan 2020
- 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: The carotid stenotic patents scheduled for carotid endarterectomy
Who may be able to join
- Every patients undergoing carotid endarterectomy in Siriraj hospital
Who cannot join
- Patients with other simultaneous surgery with carotid endarterectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Postoperative Major Adverse Cardiac Events in the Patients Underwent Carotid Endarterectomy: A Single Center Retrospective Study
Carotid endarterectomy is the operation for curing the significant carotid artery stenotic patients who are also at high cardiac risk. This retrospective study is to find out the incidence and risk factors related.
Read the detailed description
The investigator plan to retrospectively investigate 175 carotid endarterectomy patients in Siriraj hospital to find the incidences of major adverse cardiac events, including
- Myocardial infarction is defined as rising of cardiac bio-markers in the setting of myocardial ischemia (Relevant anginal symptoms, ECG changes or Imaging e.g. Echocardiography)2,10
- Significant arrhythmia is defined as symptomatic or causing hemodynamic changes without other explainable causes.
- Heart failure is defined according to Modified Framingham criteria3
- Cardiac death is defined as mortality in association and as a direct result from myocardial infarction, arrhythmia or heart failure if possible, the investigators will try to find the associate or risk factors for those events.
- Keywords
- carotid endarterectomy, adverse cardiac events
- Medical subject headings
- Carotid Stenosis, 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 after carotid endarterectomy
Major adverse cardiac event included myocardial infarction, significant arrhythmia, heart failure and cardiac arrest
Measured: 7 days
Secondary outcomes (2)
associate factors with adverse cardiac event
Analysis of potential factors associated with major adverse cardiac event after carotid endarterectomy
Measured: 7 days
other adverse events
respiratory complications, such as re-intubation, aspiration Neurologic complication, such as stroke length of hospital stay, ICU admission, length of ICU stay
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Oct 2018
- Primary completion30 Nov 2019
- Study completion15 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosisStudies 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
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aphichat Suphathamwit,, Mahidol University
- Investigators
- Aphichat Suphathamwit, M.D., Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596229
- Sponsor's protocol ID
- 2018_1
- Status last verified
- Jan 2020
- First submitted
- 5 Jul 2018
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
1. Mutirangura P et al. J Med Assoc Thai 2016; 99 (7): 785-93. 2. Boulanger M et al. Stroke. 2015 Oct;46(10):2843-8. 3. McKee PA et al. N Engl J Med. 1971 Dec 23;285(26):1441-6. 4.Go C et al. Ann Vasc Surg. 2015 Aug;29(6):1265-71. 5.Steinvil A et al. J Am Coll Cardiol. 2011 Feb 15;57(7):779-83. 6.Hoffmann R et al. Heart. 2005 Nov;91(11):1438-41. 7.Sposato LA et al. Journal of the Neurological Sciences. 2011 Oct 15;309(1-2):5-8. 8.Aboyans V et al. Eur Heart J. 2018 Mar 1;39(9):763-816. 9.Varon J, Marik PE. Vasc Health Risk Manag. 2008 Jun; 4(3): 615-627. 10.Landesberg G et al. Circulation. 2009;119:2936-2944
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Postoperative Major Adverse Cardiac Events in the Patients Underwent Carotid Endarterectomy: A Single Center Retrospective Study
- ClinicalTrials.gov ID
- NCT03596229
- Acronym / sponsor ID
- 2018_1
- Keywords
- carotid endarterectomy, adverse cardiac events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 15 Jan 2020 (actual)
- First posted
- 23 Jul 2018 (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.
Carotid endarterectomy is the operation for curing the significant carotid artery stenotic patients who are also at high cardiac risk. This retrospective study is to find out the incidence and risk factors related.
Detailed description
The investigator plan to retrospectively investigate 175 carotid endarterectomy patients in Siriraj hospital to find the incidences of major adverse cardiac events, including
- Myocardial infarction is defined as rising of cardiac bio-markers in the setting of myocardial ischemia (Relevant anginal symptoms, ECG changes or Imaging e.g. Echocardiography)2,10
- Significant arrhythmia is defined as symptomatic or causing hemodynamic changes without other explainable causes.
- Heart failure is defined according to Modified Framingham criteria3
- Cardiac death is defined as mortality in association and as a direct result from myocardial infarction, arrhythmia or heart failure if possible, the investigators will try to find the associate or risk factors for those events.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The carotid stenotic patents scheduled for carotid endarterectomy
Key inclusion criteria (1 listed)
- Every patients undergoing carotid endarterectomy in Siriraj hospital
Key exclusion criteria (1 listed)
- Patients with other simultaneous surgery with carotid endarterectomy
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 after carotid endarterectomy
Time frame: 7 days
Major adverse cardiac event included myocardial infarction, significant arrhythmia, heart failure and cardiac arrest
2 secondary outcomes
associate factors with adverse cardiac event
Time frame: 7 days
other adverse events
Time frame: 7 days
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 21 Jan 2020.
- Results publication1. Mutirangura P et al. J Med Assoc Thai 2016; 99 (7): 785-93. 2. Boulanger M et al. Stroke. 2015 Oct;46(10):2843-8. 3. McKee PA et al. N Engl J Med. 1971 Dec 23;285(26):1441-6. 4.Go C et al. Ann Vasc Surg. 2015 Aug;29(6):1265-71. 5.Steinvil A et al. J Am Coll Cardiol. 2011 Feb 15;57(7):779-83. 6.Hoffmann R et al. Heart. 2005 Nov;91(11):1438-41. 7.Sposato LA et al. Journal of the Neurological Sciences. 2011 Oct 15;309(1-2):5-8. 8.Aboyans V et al. Eur Heart J. 2018 Mar 1;39(9):763-816. 9.Varon J, Marik PE. Vasc Health Risk Manag. 2008 Jun; 4(3): 615-627. 10.Landesberg G et al. Circulation. 2009;119:2936-2944
- Individual participant dataSharing planned: No
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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.
Aphichat Suphathamwit, M.D. principal investigator
Mahidol University
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 Carotid Stenosis and Carotid Endarterectomy, run by Mahidol University at 1 site 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 1 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 21 Jan 2020. 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 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 after carotid endarterectomy (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03596229, which also lists 1 linked publication.
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 21 Jan 2020.