NCT02765607

Brief Summary

In this observational study investigators examine the presence of circulatory oscillations in blood pressure, heart rate, and doppler laser flow before and after planned cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

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

March 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

1.8 years

First QC Date

April 19, 2016

Last Update Submit

February 6, 2018

Conditions

Coronary Disease

Keywords

Blood circulationCardiac surgical proceduresHomeostasis

Outcome Measures

Primary Outcomes (1)

  • Frequency and amplitude of oscillations of electrocardiogram (ECG)

    analyzed by continuous wavelet transform

    First day

Interventions

Heart surgeryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for routine coronary artery bypass graft (CABG) surgery.

You may qualify if:

  • patients scheduled for routine coronary artery bypass graft (CABG) surgery, single procedure only

You may not qualify if:

  • no sinus or pacemaker rhythm
  • ejection fraction below 0.5
  • serious valvular disease
  • right ventricular failure
  • pulmonary hypertension
  • serious postoperative bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Trondheim University Hospital

Trondheim, 7030, Norway

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Cardiac Surgical Procedures

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Officials

  • Nils K Skjaervold, PhD

    Trondheim University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2016

First Posted

May 6, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

February 7, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)