NCT02014012

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2013

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 17, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 13, 2015

Status Verified

April 1, 2015

Enrollment Period

1.6 years

First QC Date

July 31, 2013

Last Update Submit

April 10, 2015

Conditions

C.Surgical Procedure; Cardiac

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • E/e' and e' measured by transthoracic echocardiography with color-coded tissue dopper imaging in patients undergoing non-valvular cardiac surgery

    baseline and within the first 14 days after surgery

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing cardiac surgery

You may qualify if:

  • Cardiac surgery patients who sign the informed consent

You may not qualify if:

  • Chronic renal failure (Cr\>1.5mg/dL), Dialysis patients
  • Previous stroke
  • Left ventricular dysfunction (EF \<50%)
  • ASO with claudication
  • \< 40 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 31, 2013

First Posted

December 17, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 13, 2015

Record last verified: 2015-04

Locations

KR(1)