Risk Factors of Ascending Aortic Atheromatous

• Sponsor: Mahidol University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03381222
• Collaborator: (none)
• Enrollment: 239
• Location: 1
• Actual Duration (Months): 21
• Patients Per Site Per Month: 11.4

Study Details

Study Description

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	Phase
Ascending Aortic Atheromatous Plaque	Diagnostic Test: epiaoryic scan

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 239 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Risk Factors of of Ascending Aortic Atheromatous Plaque in Thai Cardiac Surgical Patient
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Dec 30, 2019
• Actual Study Completion Date: May 31, 2020

Outcome Measures

Primary Outcome Measures

1. Incidence of ascending aortic atheromatous plaque in Thai population [1 year]

   incidence of ascending aortic atheromatous plaque

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

Age ≥ 18 years Schedule to cardiac surgery with sternotomy

Exclusion Criteria:

Abnormal ascending aortic anatomy such as: dissection, aneurysm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	faculty of medicine Siriraj hospital	Bangkok Noi	Bangkok	Thailand	10700

Sponsors and Collaborators

• Mahidol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chaowanan Khamtuikrua, principal investigator, Mahidol University
• ClinicalTrials.gov Identifier: NCT03381222
• Other Study ID Numbers: Athe001
• First Posted: Dec 21, 2017
• Last Update Posted: Sep 1, 2020
• Last Verified: Aug 1, 2020

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

Study Results

No Results Posted as of Sep 1, 2020