PWV for Cardiovascular Complication After Cardiac Surgery

C.Surgical Procedure; Cardiac Clinical Trial

Official title:

Evaluation of Pulse Wave Velocity as a Predictive Factor for Postoperative Cardiovascular Complication After Cardiac Surgery: a Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02014012
• Other study ID #: 16-2013-40
• Secondary ID: PWV-OHS
• Status: Completed
• Phase: N/A
• First received: July 31, 2013
• Last updated: April 10, 2015
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• C.Surgical Procedure; Cardiac

Locations

Country	Name	City	State
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	within the first 7 days after surgery	No
Secondary	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')	baseline and within the first 14 days after surgery	No