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

Bypass Graft Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06181565
• Other study ID #: IRBN1342021/CHUSTE
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: October 24, 2022

Study information

• Verified date: November 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 24, 2022
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bypass Graft Stenosis

Intervention

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

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow through the grafts	Datas will be collected by Medistim machine.	Minute : 1, 15
Secondary	Resistance on grafts	Datas will be collected by Medistim machine.	Minute : 1, 15
Secondary	Pulsatility of the grafts	Datas will be collected by Medistim machine.	Minute : 1, 15
Secondary	Systolic curves	Datas will be collected by Medistim machine.	Minute : 1, 15
Secondary	Diastolic curves	Datas will be collected by Medistim machine.	Minute : 1, 15