NCT03376542

Brief Summary

This is a prospective cohort study of patients undergoing coronary artery bypass graft surgery. Prior to surgery, participants will undergo submaximal cardiopulmonary exercise testing on a treadmill. Participants will be followed for one month after surgery to assess mortality and non fatal complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Aug 2017

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

August 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

1.4 years

First QC Date

November 22, 2017

Last Update Submit

March 11, 2019

Conditions

Coronary Artery DiseaseSurgery--Complications

Outcome Measures

Primary Outcomes (1)

  • Mortality after cardiac surgery

    number of deaths during the first 30 days after cardiac surgery

    30 days

Study Arms (1)

Cardiopulmonary exercise testing

EXPERIMENTAL

All patients included in the study will perform cardiopulmonary exercise testing prior to surgery

Diagnostic Test: Cardiopulmonary Exercise Testing

Interventions

Cardiopulmonary Exercise TestingDIAGNOSTIC_TEST

Cardiopulmonary exercise testing on treadmill prior to coronary artery bypass grafting surgery

Cardiopulmonary exercise testing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing coronary artery bypass grafting surgery at the National Institute of Cardiology, Ministry of Health, Rio de Jnaeiro, Brazil.

You may not qualify if:

  • Angina CCS IV, heart failure NYHA IV, inability to walk on a treadmill, severe left main coronary artery lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiology

Rio de Janeiro, 21040-360, Brazil

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Eduardo Tibiriça, MD, PhD

    National Institute of Cardiology, Laranjeiras, Brazil

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: All patients included in the study will perform cardiopulmonary exercise testing prior to surgery
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

November 22, 2017

First Posted

December 18, 2017

Study Start

August 1, 2017

Primary Completion

January 10, 2019

Study Completion

January 10, 2019

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)