Impact of Pumps on Internal Thoracic Arteries (IPITA)

NCT ID: NCT04168853

Last Updated: 2019-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-03
• Study Completion Date: 2017-12-08

Brief Summary

Cardiopulmonary bypass (CPB) induces a systemic inflammatory response and affects the organ vascular bed. Experimentally, the lack of pulsatility alters myogenic tone of resistance arteries and increases the parietal inflammatory response. The purpose of this study was to compare the vascular reactivity and the inflammatory response of the internal thoracic arteries (ITAs) between patients undergoing coronary artery bypass grafting (CABG) under CPB with a roller pump or with a centrifugal pump.

Detailed Description

Eighty elective male patients undergoing CABG were selected using one or two internal thoracic arteries under CPB with a roller pump (RP group) or centrifugal pump (CFP group). ITA samples were collected before starting CPB (Time 1) and before the last coronary anastomosis during aortic cross clamping (Time 2). Terminal complement complex activation (SC5b-9) and neutrophil activation (elastase) analysis were performed on arterial blood at the same times.

Conditions

Coronary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Roller pump group

CABG was performed under normothermic (36-37°C) cardiopulmonary bypass (CPB). All components of the circuits were coated with phosphorylcholine inert surface (PHISIO, Sorin®). The pump manufacturer is Maquet® for the roller pumps.1.5 cm of ITA distality was sampled before blood flow interruption into the graft and before starting CPB (Time 1) and another segment (1.5 cm) before the last coronary anastomosis during aortic cross clamping (Time 2) (Figure 1). Each arterial segment was cut into three parts: a fresh part for arterial myography bathed and stored in a 50 ml organ bath containing a physiological salt solution (PSS). The other two parts were cooled in liquid nitrogen and stored at -80°C for immunohistochemistry and RT-PCR analysis.

Group Type: OTHER

vascular reactivity of internal thoracic arteries

Intervention Type: DIAGNOSTIC_TEST

1. Internal thoracic arteries analysis Myography Superoxide detection and confocal microscopy Immunochemistry Quantitative real time transcription-polymerase chain reaction (RT-PCR) analysis

2. Blood sampling and biochemical analysis

Centrifugal pump group

CABG was performed under normothermic (36-37°C) cardiopulmonary bypass (CPB). All components of the circuits were coated with phosphorylcholine inert surface (PHISIO, Sorin®). The pump manufacturer is Sorin® for the centrifugal pumps.1.5 cm of ITA distality was sampled before blood flow interruption into the graft and before starting CPB (Time 1) and another segment (1.5 cm) before the last coronary anastomosis during aortic cross clamping (Time 2) (Figure 1). Each arterial segment was cut into three parts: a fresh part for arterial myography bathed and stored in a 50 ml organ bath containing a physiological salt solution (PSS). The other two parts were cooled in liquid nitrogen and stored at -80°C for immunohistochemistry and RT-PCR analysis.

Group Type: OTHER

vascular reactivity of internal thoracic arteries

Intervention Type: DIAGNOSTIC_TEST

1. Internal thoracic arteries analysis Myography Superoxide detection and confocal microscopy Immunochemistry Quantitative real time transcription-polymerase chain reaction (RT-PCR) analysis

2. Blood sampling and biochemical analysis

Interventions

vascular reactivity of internal thoracic arteries

1. Internal thoracic arteries analysis Myography Superoxide detection and confocal microscopy Immunochemistry Quantitative real time transcription-polymerase chain reaction (RT-PCR) analysis

2. Blood sampling and biochemical analysis

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• male patients and elective coronary artery bypass grafting using at least one of the two ITAs.

Exclusion Criteria

• female patients because their complement activation has been shown to be greater than that in men during surgery under cardiopulmonary bypass ; age < 18 years; CABG requiring additional valve repair or replacement; emergency surgery and insufficient length of the internal thoracic artery

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Fouquet O, Dang Van S, Baudry A, Meisnerowski P, Robert P, Pinaud F, Binuani P, Chretien JM, Henrion D, Baufreton C, Loufrani L. Cardiopulmonary bypass and internal thoracic artery: Can roller or centrifugal pumps change vascular reactivity of the graft? The IPITA study: A randomized controlled clinical trial. PLoS One. 2020 Jul 9;15(7):e0235604. doi: 10.1371/journal.pone.0235604. eCollection 2020.

Reference Type: DERIVED

PMID: 32645079 (View on PubMed)

Other Identifiers

CHU Angers

Identifier Type: -

Identifier Source: org_study_id