Risk Factors of Ascending Aortic Atheromatous

Ascending Aortic Atheromatous Plaque Clinical Trial

Official title:

Risk Factors of of Ascending Aortic Atheromatous Plaque in Thai Cardiac Surgical Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381222
• Other study ID #: Athe001
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Ascending Aortic Atheromatous Plaque
• Plaque, Atherosclerotic

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