- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02014012
PWV for Cardiovascular Complication After Cardiac Surgery
April 10, 2015 updated by: Jae-Sung Choi, MD. PhD., Seoul National University Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of, 156-707
- SMG-SNU Boramae Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing cardiac surgery
Description
Inclusion Criteria:
- Cardiac surgery patients who sign the informed consent
Exclusion Criteria:
- Chronic renal failure (Cr>1.5mg/dL), Dialysis patients
- Previous stroke
- Left ventricular dysfunction (EF <50%)
- ASO with claudication
- < 40 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
within the first 7 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
peak early transmitral filling velocity during early diastole (E), mean early velocity at the septal mitral annulus (e')
|
baseline and within the first 14 days after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
July 31, 2013
First Submitted That Met QC Criteria
December 11, 2013
First Posted (Estimate)
December 17, 2013
Study Record Updates
Last Update Posted (Estimate)
April 13, 2015
Last Update Submitted That Met QC Criteria
April 10, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- 16-2013-40
- PWV-OHS (Other Identifier: SMG-SNU Boramae Medical Center)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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