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

NCT ID: NCT06181565

Last Updated: 2023-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-10-24

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bypass Graft Stenosis

Keywords

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Cardiac surgery pericardial closure grafts bypass aortocoronary bypass

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Datas of Medistim machine

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Medistim machine

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andranik PETROSYAN, MD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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IRBN1342021/CHUSTE

Identifier Type: -

Identifier Source: org_study_id