NCT02433951

Brief Summary

In this study, up to 20 healthy individuals, 20 endo-ACAB patients, and 20 CABG patients undergo a maximal cardiopulmonary exercise test after hospital discharge (for patients only). Exercise tolerance is compared between groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

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

February 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

4 months

First QC Date

April 24, 2015

Last Update Submit

August 17, 2015

Conditions

Coronary Artery Bypass Surgery

Keywords

exercise tolerance

Outcome Measures

Primary Outcomes (1)

  • VO2peak (peak oxygen uptake)

    Peak oxygen uptake capacity, expressed as ml/min.

    At peak exercise, single measurement which is executed between 2-4 weeks after surgery.

Study Arms (3)

healthy individuals

Age, gender and BMI matched healthy subjects without any chronic disease or physical disability, and being sedentary.

Other: Cardiopulmonary exercise test

CABG patients

Age, gender and BMI matched CABG patients, without neurologic, nephrologic, respiratory disease.

Other: Cardiopulmonary exercise test

endo-ACAB patients

Age, gender and BMI matched endo-ACAB patients without neurologic, nephrologic, respiratory disease.

Other: Cardiopulmonary exercise test

Interventions

Cardiopulmonary exercise testOTHER

Maximal exercise test with ergospirometry.

CABG patientsendo-ACAB patientshealthy individuals

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing CABG surgery or endo-ACAB surgery.

You may qualify if:

  • undergoing this type of surgery. For healthy subjects: must be sedentary.

You may not qualify if:

  • any neurologic, nephrologic, respiratory disease. For healthy subjects: any chronic disease or condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, 3500, Belgium

Location

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Officials

  • Paul Dendale

    Jessa Hospital, Stadsomvaart 11, 3500 Hasselt, Belgium

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

April 24, 2015

First Posted

May 5, 2015

Study Start

February 1, 2015

Primary Completion

June 1, 2015

Study Completion

July 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

BE(1)