Troponin Clinical Trial
Official title:
Effect of O2 Tension on Myocardial Injury During TAVI
NCT number | NCT03291210 |
Other study ID # | TAVI-O2 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 18, 2017 |
Est. completion date | July 18, 2022 |
Verified date | July 2022 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02285686 -
Prognostic Value of Elevated Troponins in Critical Illness Study: A Pilot Study
|
N/A | |
Completed |
NCT06468982 -
Use of Intra-aortic Balloon Pump Before Surgery for Acute Myocardial Infarction
|
N/A | |
Active, not recruiting |
NCT03259737 -
An Observational Study of Stroke Patients.
|
||
Active, not recruiting |
NCT03507309 -
National Institute for Health Research (NIHR) Health Informatics Collaborative Troponin Study
|
||
Completed |
NCT00560040 -
Myocardial Injury is Not Related to Training Levels Among Recreational Participants in the Silicon Valley Marathon
|
N/A | |
Completed |
NCT03400553 -
Troponin POCT in the Diagnosis of an Acute Myocardial Infarction
|
N/A | |
Completed |
NCT02060760 -
Use of Abbott High Sensitivity Troponin I Assay In Acute Coronary Syndromes
|
||
Recruiting |
NCT04508244 -
Beta Blocker Use In Traumatic Brain Injury Based On The High-Sensitive Troponin T Status
|
Phase 4 | |
Recruiting |
NCT05322395 -
Pragmatic Randomised Trial of the ESC 0/1 Versus 0/3 Hour Troponin Pathway
|
N/A |