Ascending Aortic Atheromatous Plaque Clinical Trial
Official title:
Risk Factors of of Ascending Aortic Atheromatous Plaque in Thai Cardiac Surgical Patient
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 |
Verified date | August 2020 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | faculty of medicine Siriraj hospital | Bangkok Noi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University |
Thailand,
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 |