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

NCT06181565 | Completed

• 1 other identifier: IRBN1342021/CHUSTE
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bypass Graft Stenosis

Keywords

Cardiac surgery; pericardial closure; grafts; bypass; aortocoronary bypass

Outcome Measures

Primary Outcomes (1)

• Flow through the grafts

  Datas will be collected by Medistim machine.

  Minute : 1, 15

Secondary Outcomes (4)

• Resistance on grafts

  Minute : 1, 15

• Pulsatility of the grafts

  Minute : 1, 15

• Systolic curves

  Minute : 1, 15

• Diastolic curves

  Minute : 1, 15

Study Arms (1)

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

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

Also known as: Medistim machine

Patients who will have isolated aortocoronary bypass grafting surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All patients who will have isolated aortocoronary bypass grafting surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint-Etienne

Saint-Etienne, France

Location

Study Officials

• Andranik PETROSYAN, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 26, 2023
• Study Start: January 1, 2022
• Primary Completion: October 24, 2022
• Study Completion: October 24, 2022
• Last Updated: December 26, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)