O2 Tension During TAVI

Troponin Clinical Trial

Official title:

Effect of O2 Tension on Myocardial Injury During TAVI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03291210
• Other study ID #: TAVI-O2
• Status: Completed
• Phase: N/A
• Start date: October 18, 2017
• Est. completion date: July 18, 2022

Study information

• Verified date: July 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hyperoxemia can produce various complications including oxidative stress and myocardial injury. We hypothesized that the normoxic group would have lower myocardial injury compared to hyperoxic group after transcatheter aortic valve replacement.

Description:

Hyperoxemia can produce various complications, such as excessive oxidative stress, hyperoxia-induced vasoconstriction, increased perfusion heterogeneity, and resultant myocardial injury. Previous studies have been observed higher mortality in patient group maintained with supranormal oxygenation after resuscitation from cardiac arrest. However, the effect of hyperoxia vs. normoxia on myocardial injury during transcatheter aortic valve replacement (TAVR) has not been well investigated. We hypothesized that the normoxic group would have lower myocardial injury compared to hyperoxic group after TAVR.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 18, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

• Scheduled for transcatheter aortic valve replacement due to aortic stenosis

Exclusion Criteria:

• Transapical approach

• Pre-procedural PaO2 < 65 mmHg or oxygen support therapy

• Pre-procedural severe kidney injury (end-stage renal disease)

• Pre-procedural chronic pulmonary disease, symptomatic asthma

• Pre-procedural Tb-destroyed lung

• Lung cancer

• History of acute coronary syndrome within 6 months

• Pre-procedural elevated Troponin I or CKMB

• History of stroke or transient ischemic attack within 6 months

• Refuse to participate

• Pregnant

Related Conditions & MeSH terms

• Troponin

Intervention

Other:
• normal inspired oxygen fraction
receives inspired oxygen fraction of 0.3
• high inspired oxygen fraction
receives inspired oxygen fraction of 0.8

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Troponin I	Area under the curve of troponin I	72 hours after the end of procedure
Secondary	CK MB	Area under the curve of CK MB	72 hours after the end of procedure
Secondary	Changes in cerebral oximetry	changes in cerebral oximetry during the procedure	through procedure completion, an average of 3 hours
Secondary	Delirum	Newly onset delirium	through admission completion, an average of 5 days
Secondary	AKI or RRT	Newly onset acute kidney injury or renal replacement therapy	through admission completion, an average of 5 days
Secondary	stroke, myocardial infarction or mortality	Newly onset stroke, myocardial infarction or mortality	through admission completion, an average of 5 days