C.Surgical Procedure; CardiacNCT02014012
PWV for Cardiovascular Complication After Cardiac Surgery
An observational study of C.Surgical Procedure; Cardiac, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Arterial stiffness has been suggested as an independent risk factor for the development of coronary artery disease and stroke. Pulse wave velocity (PWV) is an noninvasive established index to quantify arterial stiffness. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- C.Surgical Procedure; Cardiac
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2013to Nov 2014
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery
Who may be able to join
- Cardiac surgery patients who sign the informed consent
Who cannot join
- Chronic renal failure (Cr>1.5mg/dL), Dialysis patients
- Previous stroke
- Left ventricular dysfunction (EF <50%)
- ASO with claudication
- < 40 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pulse Wave Velocity as a Predictive Factor for Postoperative Cardiovascular Complication After Cardiac Surgery: a Prospective Study
Arterial stiffness has been suggested as an independent risk factor for the development of coronary artery disease and stroke. Pulse wave velocity (PWV) is an noninvasive established index to quantify arterial stiffness. Therefore, we try to investigate the correlation between PWV values and cardiovascular complications like stroke, acute renal failure, or perioperative myocardial infarction after cardiac surgery.
- Conditions
- C.Surgical Procedure; Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative cardiovascular complication and parameters
Stroke, Delirium, Newly developed atrial fibrillation, ARF, Peak CK-MB and troponin I levels measured at 12 and 24 hours after surgery, Peak estimated GFR and corresponding creatinine
Measured: within the first 7 days after surgery
Secondary outcomes (1)
E/e' and e' measured by transthoracic echocardiography with color-coded tissue dopper imaging in patients undergoing non-valvular cardiac surgery
peak early transmitral filling velocity during early diastole (E), mean early velocity at the septal mitral annulus (e')
Measured: baseline and within the first 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Surgical Procedure; CardiacStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Jae-Sung Choi, MD. PhD., Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02014012
- Sponsor's protocol ID
- 16-2013-40
- Other IDs
- PWV-OHS
- Status last verified
- Apr 2015
- First submitted
- 31 Jul 2013
- Last updated
- 13 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pulse Wave Velocity as a Predictive Factor for Postoperative Cardiovascular Complication After Cardiac Surgery: a Prospective Study
- ClinicalTrials.gov ID
- NCT02014012
- Acronym / sponsor ID
- 16-2013-40
- Conditions
- C.Surgical Procedure; Cardiac
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- Apr 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Dec 2013 (estimated)
- 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.
Arterial stiffness has been suggested as an independent risk factor for the development of coronary artery disease and stroke. Pulse wave velocity (PWV) is an noninvasive established index to quantify arterial stiffness. Therefore, we try to investigate the correlation between PWV values and cardiovascular complications like stroke, acute renal failure, or perioperative myocardial infarction after cardiac surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 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)
- Cardiac surgery patients who sign the informed consent
Key exclusion criteria (5 listed)
- Chronic renal failure (Cr>1.5mg/dL), Dialysis patients
- Previous stroke
- Left ventricular dysfunction (EF <50%)
- ASO with claudication
- < 40 years
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
Postoperative cardiovascular complication and parameters
Time frame: within the first 7 days after surgery
Stroke, Delirium, Newly developed atrial fibrillation, ARF, Peak CK-MB and troponin I levels measured at 12 and 24 hours after surgery, Peak estimated GFR and corresponding creatinine
1 secondary outcome
E/e' and e' measured by transthoracic echocardiography with color-coded tissue dopper imaging in patients undergoing non-valvular cardiac surgery
Time frame: baseline and within the first 14 days after surgery
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 13 Apr 2015.
Related trials for C.Surgical Procedure; Cardiac
Active, not recruiting
Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
C.Surgical Procedure; Cardiac
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 C.Surgical Procedure; Cardiac, 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 5 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 13 Apr 2015. 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?
Postoperative cardiovascular complication and parameters (time frame: within the first 7 days after surgery). 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 13 Apr 2015.