Postoperative ComplicationsNCT03201289
Microvolt T-wave Alternans in Cardiac Surgery Patients
An observational study of Postoperative Complications and Electrocardiogram: Electrical Alternans, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to measure MTWA in the patients undergoing cardiac surgery and to investigate the relation between MTWA and adverse clinical outcomes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Postoperative Complications, Electrocardiogram: Electrical Alternans
- How many people
- 224 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to 29 Dec 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery
Who may be able to join
- All patients underwent cardiac surgery including coronary artery bypass graft surgery with or without cardiopulmonary bypass, cardiac valve surgery, cardiac mass excision, thoracic aorta surgery, etc.
Who cannot join
- unavailability of the recording equipment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to measure MTWA in the patients undergoing cardiac surgery and to investigate the relation between MTWA and adverse clinical outcomes.
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
in hospital mortality
in hospital death
Measured: up to 3 months(during hospital stay)
Secondary outcomes (1)
postoperative complication
The secondary end points were myocardial infarction, ventricular tachycardia, atrial fibrillation, cardiogenic shock, stroke, coma, renal failure, respiratory failure, and length of stay in intensive care unit (ICU) and hospital.
Measured: up to 3 months(during hospital stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study startJan 2013
- Primary completion29 Dec 2016
- Study completion29 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 224 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201289
- Sponsor's protocol ID
- MTWA
- Status last verified
- Jun 2017
- First submitted
- 16 Jun 2017
- Last updated
- 28 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvolt T-wave Alternans in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT03201289
- Acronym / sponsor ID
- MTWA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- 29 Dec 2016 (actual)
- Study completion
- 29 Dec 2016 (actual)
- First posted
- 28 Jun 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.
The purpose of this study is to measure MTWA in the patients undergoing cardiac surgery and to investigate the relation between MTWA and adverse clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery | – | – |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery
Key inclusion criteria (1 listed)
- All patients underwent cardiac surgery including coronary artery bypass graft surgery with or without cardiopulmonary bypass, cardiac valve surgery, cardiac mass excision, thoracic aorta surgery, etc.
Key exclusion criteria (1 listed)
- unavailability of the recording equipment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
in hospital mortality
Time frame: up to 3 months(during hospital stay)
in hospital death
1 secondary outcome
postoperative complication
Time frame: up to 3 months(during hospital stay)
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 28 Jun 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Electrocardiogram: Electrical Alternans, 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 1 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 28 Jun 2017. 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?
in hospital mortality (time frame: up to 3 months(during hospital stay)). 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 28 Jun 2017.