CClinicalTrials.gg
CompletedNCT06181565Updated Dec 26, 2023

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

An observational study in Bypass Graft Stenosis, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-26.

Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
34
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Bypass Graft Stenosis

Keywords

  • Cardiac surgery
  • pericardial closure
  • grafts
  • bypass
  • aortocoronary bypass
03

In context

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • All patients who will have isolated aortocoronary bypass grafting surgery

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
34 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherDatas 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

    Also known as: Medistim machine

06

What researchers measure

Primary outcomes

  1. Flow through the grafts

    Datas will be collected by Medistim machine.

    Time frame: Minute : 1, 15

Secondary outcomes

  1. Resistance on grafts

    Datas will be collected by Medistim machine.

    Time frame: Minute : 1, 15

  2. Pulsatility of the grafts

    Datas will be collected by Medistim machine.

    Time frame: Minute : 1, 15

  3. Systolic curves

    Datas will be collected by Medistim machine.

    Time frame: Minute : 1, 15

  4. Diastolic curves

    Datas will be collected by Medistim machine.

    Time frame: Minute : 1, 15

07

Study locations

1 site
  • Chu Saint-Etienne
    Saint-Étienne, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06181565
Lead sponsor
Centre Hospitalier Universitaire de Saint Etienne
Responsible party
Sponsor
First posted
Dec 26, 2023
Start date
Jan 1, 2022
Primary completion
Oct 24, 2022
Completion
Oct 24, 2022
Last update
Dec 26, 2023

Study contacts

Andranik PETROSYAN, MD
principal investigator · CHU SAINT-ETIENNE

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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