TroponinNCT03291210
O2 Tension During TAVI
A study testing normal inspired oxygen fraction and high inspired oxygen fraction in people with Troponin, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Troponin
- What is being tested?
- normal inspired oxygen fraction and high inspired oxygen fraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Oct 2017to 18 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled for transcatheter aortic valve replacement due to aortic stenosis
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of O2 Tension on Myocardial Injury During TAVI
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.
Read the detailed 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.
- Conditions
- Troponin
- Being tested
- normal inspired oxygen fraction, high inspired oxygen fraction
- Keywords
- hyperoxemia, myocardial injury, transcatheter aortic valve replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal inspired oxygen fractionOther
receives inspired oxygen fraction of 0.3
high inspired oxygen fractionOther
receives inspired oxygen fraction of 0.8
| Study group | Role | What they receive |
|---|---|---|
| Normoxemia | Experimental | Patients randomized to the normoxemia group receives inspired oxygen fraction of 0.3 from initiation of induction of anesthesia to the end of the procedure. Receives: Other: normal inspired oxygen fraction |
| Hyperoxemia | Active comparator | Patients randomized to the hyperoxemia group receives inspired oxygen fraction of 0.8 from initiation of induction of anesthesia to the end of the procedure. Receives: Other: high inspired oxygen fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin I
Area under the curve of troponin I
Measured: 72 hours after the end of procedure
Secondary outcomes (5)
CK MB
Area under the curve of CK MB
Measured: 72 hours after the end of procedure
Changes in cerebral oximetry
changes in cerebral oximetry during the procedure
Measured: through procedure completion, an average of 3 hours
Delirum
Newly onset delirium
Measured: through admission completion, an average of 5 days
AKI or RRT
Newly onset acute kidney injury or renal replacement therapy
Measured: through admission completion, an average of 5 days
stroke, myocardial infarction or mortality
Newly onset stroke, myocardial infarction or mortality
Measured: through admission completion, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start18 Oct 2017
- Primary completion6 Apr 2022
- Study completion18 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TroponinStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunseok Jeon, Seoul National University Hospital
- Investigators
- Yunseok Jeon, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291210
- Sponsor's protocol ID
- TAVI-O2
- Status last verified
- Jul 2022
- First submitted
- 18 Sep 2017
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of O2 Tension on Myocardial Injury During TAVI
- ClinicalTrials.gov ID
- NCT03291210
- Acronym / sponsor ID
- TAVI-O2
- Conditions
- Troponin
- Keywords
- hyperoxemia, myocardial injury, transcatheter aortic valve replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 18 Jul 2022 (actual)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normoxemia | Experimental | Other: normal inspired oxygen fractionPatients randomized to the normoxemia group receives inspired oxygen fraction of 0.3 from initiation of induction of anesthesia to the end of the procedure. |
| Hyperoxemia | Active comparator | Other: high inspired oxygen fractionPatients randomized to the hyperoxemia group receives inspired oxygen fraction of 0.8 from initiation of induction of anesthesia to the end of the procedure. |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled for transcatheter aortic valve replacement due to aortic stenosis
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal inspired oxygen fractionreceives inspired oxygen fraction of 0.3 | Other | Normoxemia |
| high inspired oxygen fractionreceives inspired oxygen fraction of 0.8 | Other | Hyperoxemia |
Primary outcome
Troponin I
Time frame: 72 hours after the end of procedure
Area under the curve of troponin I
5 secondary outcomes
CK MB
Time frame: 72 hours after the end of procedure
Changes in cerebral oximetry
Time frame: through procedure completion, an average of 3 hours
Delirum
Time frame: through admission completion, an average of 5 days
AKI or RRT
Time frame: through admission completion, an average of 5 days
stroke, myocardial infarction or mortality
Time frame: through admission completion, an average of 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunseok Jeon, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal inspired oxygen fraction and high inspired oxygen fraction in people with Troponin, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Troponin I (time frame: 72 hours after the end of procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.