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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03381222
Other study ID # Athe001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date May 31, 2020

Study information

Verified date August 2020
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 239
Est. completion date May 31, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

Age = 18 years Schedule to cardiac surgery with sternotomy

Exclusion Criteria:

Abnormal ascending aortic anatomy such as: dissection, aneurysm

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Thailand faculty of medicine Siriraj hospital Bangkok Noi Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of ascending aortic atheromatous plaque in Thai population incidence of ascending aortic atheromatous plaque 1 year