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Risk Factors of Ascending Aortic Atheromatous

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03381222
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Chaowanan Khamtuikrua, Mahidol University

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Ascending Aortic Atheromatous Plaque Diagnostic Test: epiaoryic scan

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 239 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Risk Factors of of Ascending Aortic Atheromatous Plaque in Thai Cardiac Surgical Patient
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : December 30, 2019
Actual Study Completion Date : May 31, 2020
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: epiaoryic scan
    Epiaortic scan will be performed by use L15-7i Phillips®. Ultrasound probe cover with sterile cover. Five standard epiaortic views will be collected

Outcome Measures
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Primary Outcome Measures :
  1. Incidence of ascending aortic atheromatous plaque in Thai population [ Time Frame: 1 year ]
    incidence of ascending aortic atheromatous plaque


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Age ≥ 18 years and schedule to cardiac surgery with sternotomy.
Criteria

Inclusion Criteria:

Age ≥ 18 years Schedule to cardiac surgery with sternotomy

Exclusion Criteria:

Abnormal ascending aortic anatomy such as: dissection, aneurysm

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381222


Locations
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Thailand
faculty of medicine Siriraj hospital
Bangkok Noi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
More Information
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Additional Information:

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Responsible Party: Chaowanan Khamtuikrua, principal investigator, Mahidol University
ClinicalTrials.gov Identifier: NCT03381222    
Other Study ID Numbers: Athe001
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Plaque, Atherosclerotic
Pathological Conditions, Anatomical