The Impact of Pericardial Closure on the Grafts, in the Context of Coronary Artery Bypass Grafting

December 20, 2023 updated by: Centre Hospitalier Universitaire de Saint Etienne

Once the pericardium is closed, there is no information on the hemodynamics of the grafts after coronary artery bypass grafting. This would be the reason for different opinions on pericardial closure: some teams do not close the pericardium and others close it.

In the department Cardiovascular Surgery of the University Hospital of Saint-Etienne, the Medistim machine is used in routine and the hemodynamic properties of the grafts are recorded immediately after the bypass surgery, before the closure of the pericardium.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to have hemodynamic information immediately after the closure of the pericardium using the Medistim machine. The prospective study will be conducted on 50 patients, who will be selected consecutively without randomization. The inclusion and exclusion criteria are determined.

Study Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Étienne, France
        • CHU Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who will have isolated aortocoronary bypass grafting surgery will be included.

Description

Inclusion Criteria:

  • All patients who will have isolated aortocoronary bypass grafting surgery

Exclusion Criteria:

  • History of thoracic trauma
  • Severe cyphosis
  • Severe thoracic deformity (Pectus excavatum)
  • Pericardial disease
  • History of radiotherapy
  • Severe pulmonary disease (emphysema)
  • Right heart failure
  • Redo surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who will have isolated aortocoronary bypass grafting surgery

Patients who will have isolated aortocoronary bypass grafting surgery will be included.

The Medistim machine will be use before and after pericardial closure. Datas will be collected and analysis.
Other: Datas of Medistim machine
Datas will be collected by Medistim machine before and after pericardial closure: Flow through the grafts, Resistance on grafts, Pulsatility of the grafts, Systolic and diastolic curves before and after pericardial closure
Other Names:
  • Medistim machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow through the grafts
Time Frame: Minute : 1, 15
Datas will be collected by Medistim machine.
Minute : 1, 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resistance on grafts
Time Frame: Minute : 1, 15
Datas will be collected by Medistim machine.
Minute : 1, 15
Pulsatility of the grafts
Time Frame: Minute : 1, 15
Datas will be collected by Medistim machine.
Minute : 1, 15
Systolic curves
Time Frame: Minute : 1, 15
Datas will be collected by Medistim machine.
Minute : 1, 15
Diastolic curves
Time Frame: Minute : 1, 15
Datas will be collected by Medistim machine.
Minute : 1, 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Andranik PETROSYAN, MD, CHU Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

October 24, 2022

Study Completion (Actual)

October 24, 2022

Study Registration Dates

First Submitted

November 23, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

December 26, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRBN1342021/CHUSTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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