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Completed

NCT Number: NCT06181565

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

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.

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Key information

Conditions

Bypass Graft Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Saint-Etienne

Saint-Etienne, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Datas of Medistim machine

Other

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

Primary outcomes

  1. Flow through the grafts

    Time frame: Minute : 1, 15

    Datas will be collected by Medistim machine.

Secondary outcomes

  1. Resistance on grafts

    Time frame: Minute : 1, 15

    Datas will be collected by Medistim machine.

  2. Pulsatility of the grafts

    Time frame: Minute : 1, 15

    Datas will be collected by Medistim machine.

  3. Systolic curves

    Time frame: Minute : 1, 15

    Datas will be collected by Medistim machine.

  4. Diastolic curves

    Time frame: Minute : 1, 15

    Datas will be collected by Medistim machine.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Dec 26, 2023
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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