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CompletedNCT03381222Updated Sep 1, 2020

Risk Factors of Ascending Aortic Atheromatous

An observational study in Ascending Aortic Atheromatous Plaque, sponsored by Mahidol University. Completed at 1 site in Thailand. Per ClinicalTrials.gov, last updated 2020-09-01.

Sponsored by Mahidol University · Observational

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
239
Sex
All
01

Study 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 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.

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Conditions studied

  • Ascending Aortic Atheromatous Plaque
03

In context

Plaque, Atherosclerotic

105 studies on the registry are indexed under Plaque, Atherosclerotic; 27 are open to participants now.

This study's enrollment of 239 is above the median of 146 across 50 observational studies indexed under Plaque, Atherosclerotic.

Browse Plaque, Atherosclerotic studies →

Lead sponsor

Mahidol University is the lead sponsor of 747 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Age ≥ 18 years and schedule to cardiac surgery with sternotomy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Age ≥ 18 years Schedule to cardiac surgery with sternotomy

Exclusion criteria

Exclusion Criteria:

Abnormal ascending aortic anatomy such as: dissection, aneurysm

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
239 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Interventions

  • Diagnostic testepiaoryic scan

    Epiaortic scan will be performed by use L15-7i Phillips®. Ultrasound probe cover with sterile cover. Five standard epiaortic views will be collected

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What researchers measure

Primary outcomes

  1. Incidence of ascending aortic atheromatous plaque in Thai population

    incidence of ascending aortic atheromatous plaque

    Time frame: 1 year

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Study locations

1 site
  • faculty of medicine Siriraj hospital
    Bangkok Noi, Bangkok 10700, Thailand
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in Dec 2019, 15 months.

Of 31 observational studies under Plaque, Atherosclerotic, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 105. This study's 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2017
First posted
Dec 21, 2017
StartActual
Sep 1, 2018
Primary completionActual
Dec 30, 2019
CompletionActual
May 31, 2020
Last update
Sep 1, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03381222
Lead sponsor
Mahidol University
Responsible party
Chaowanan Khamtuikrua (principal investigator, Mahidol University) — Principal investigator
First posted
Dec 21, 2017
Start date
Sep 1, 2018
Primary completion
Dec 30, 2019
Completion
May 31, 2020
Last update
Sep 1, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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