Ascending Aortic Atheromatous PlaqueNCT03381222
Risk Factors of Ascending Aortic Atheromatous
An observational study of Ascending Aortic Atheromatous Plaque, run by Mahidol University at 1 site in Thailand.
Trial summary
Background Incidence of perioperative stroke In cardiac surgery is 2.6-5.2%. Ascending aortic atheromatous plaque and stroke are strongly associated. Propose of study To determine incidence of ascending aortic atheroma in Thai people To identify risk factors which associated with ascending aortic atheroma Methodology… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ascending Aortic Atheromatous Plaque
- What is being tested?
- epiaoryic scan
- How many people
- 239 participants
- Where
- 1 siteThailand
- Study dates
- 1 Sep 2018to 31 May 2020
- How long will I take part?
- 1 Year
- 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
- Child, Adult, Older adult
Study population: Age ≥ 18 years and schedule to cardiac surgery with sternotomy.
Who may be able to join
- Age ≥ 18 years Schedule to cardiac surgery with sternotomy
Who cannot join
- Abnormal ascending aortic anatomy such as: dissection, aneurysm
Trial locations and contacts
1 site in 1 country.
Thailand1 site
faculty of medicine Siriraj hospital
Bangkok Noi, Bangkok, 10700
About this study
Official title: Risk Factors of of Ascending Aortic Atheromatous Plaque in Thai Cardiac Surgical Patient
Background Incidence of perioperative stroke In cardiac surgery is 2.6-5.2%. Ascending aortic atheromatous plaque and stroke are strongly associated.
Propose of study To determine incidence of ascending aortic atheroma in Thai people To identify risk factors which associated with ascending aortic atheroma
Read more
Methodology After received standard general anesthesia and start sternotomy. Epiaortic scan will be performed by surgeon use L15-7i Phillips® ultrasound probe cover with sterile cover.
Five standard epiaortic views will be collected. Epiaortic clips will be review and determine about atheroma by two qualified echocardiographers. Atheroma more than third grade will defined to significant. Potential risk factors of atheroma will be gather from medical record
To assess the relationship between risk factors and atheroma a univariate analysis was performed using an unpaired t-test and a Chi-square test.
For higher accuracy regarding the impact of single risk factors, a multiple logistic regression analysis was also performed.
- Conditions
- Ascending Aortic Atheromatous Plaque
- Being tested
- epiaoryic scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epiaoryic scanDiagnostic test
Epiaortic scan will be performed by use L15-7i Phillips®. Ultrasound probe cover with sterile cover. Five standard epiaortic views will be collected
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ascending aortic atheromatous plaque in Thai population
incidence of ascending aortic atheromatous plaque
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start1 Sep 2018
- Primary completion30 Dec 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ascending Aortic Atheromatous PlaqueStudies 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
- Prospective
- Enrolment
- 239 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chaowanan Khamtuikrua, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381222
- Sponsor's protocol ID
- Athe001
- Status last verified
- Aug 2020
- First submitted
- 18 Dec 2017
- Last updated
- 1 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of of Ascending Aortic Atheromatous Plaque in Thai Cardiac Surgical Patient
- ClinicalTrials.gov ID
- NCT03381222
- Acronym / sponsor ID
- Athe001
- Conditions
- Ascending Aortic Atheromatous Plaque
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 21 Dec 2017 (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.
Background Incidence of perioperative stroke In cardiac surgery is 2.6-5.2%. Ascending aortic atheromatous plaque and stroke are strongly associated.
Propose of study To determine incidence of ascending aortic atheroma in Thai people To identify risk factors which associated with ascending aortic atheroma
Methodology After received standard general anesthesia and start sternotomy. Epiaortic scan will be performed by surgeon use L15-7i Phillips® ultrasound probe cover with sterile cover.
Five standard epiaortic views will be collected. Epiaortic clips will be review and determine about atheroma by two qualified echocardiographers. Atheroma more than third grade will defined to significant. Potential risk factors of atheroma will be gather from medical record
To assess the relationship between risk factors and atheroma a univariate analysis was performed using an unpaired t-test and a Chi-square test.
For higher accuracy regarding the impact of single risk factors, a multiple logistic regression analysis was also performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Age ≥ 18 years and schedule to cardiac surgery with sternotomy.
Key inclusion criteria (1 listed)
- Age ≥ 18 years Schedule to cardiac surgery with sternotomy
Key exclusion criteria (1 listed)
- Abnormal ascending aortic anatomy such as: dissection, aneurysm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epiaoryic scanEpiaortic scan will be performed by use L15-7i Phillips®. Ultrasound probe cover with sterile cover. Five standard epiaortic views will be collected | Diagnostic test | – |
Primary outcome
Incidence of ascending aortic atheromatous plaque in Thai population
Time frame: 1 year
incidence of ascending aortic atheromatous plaque
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 1 Sep 2020.
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 Ascending Aortic Atheromatous Plaque, 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 1 Sep 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 ascending aortic atheromatous plaque in Thai population (time frame: 1 year). 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 1 Sep 2020.