Impact of Pumps on Internal Thoracic Arteries (IPITA)

NCT04168853 | Completed DMC

• 1 other identifier: CHU Angers
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Disease

Keywords

cardiopulmonary bypass; pulsatility; systemic inflammatory response; arterial graft

Outcome Measures

Primary Outcomes (1)

• Myography

  for each patient, 2 fresh segments of ITA (Time 1 and Time 2) stored in PSS were analyzed. On day+1, these segments were mounted on a wire-myograph (DMT, Aarhens, DK) . Two tungsten wires (25 μm diameter) were inserted into the lumen of the arteries and connected to a force transducer and a micrometer, respectively. The arteries were bathed in the PSS solution. Wall tension, equivalent to intra-arterial pressure (90 mmHg), was applied and the blood vessels were allowed to stabilize for thirty minutes. Arterial contractility was assessed with phenylephrine (PE, 10 μmol/L). Acetylcholine-induced (Ach 10 μmol/L) relaxation was then obtained after phenylephrine-induced preconstruction (50% of maximal contraction) in the presence or in the absence of the NO synthesis blocker L-NMMA (3.10-4 mol/L) and in the presence or in the absence of the COX synthesis blocker Indomethacin (10-5 mol/L).

  1 day

Secondary Outcomes (4)

• Superoxide detection and confocal microscopy

  1 day

• Immunochemistry

  1 day

• Quantitative real time transcription-polymerase chain reaction (RT-PCR) analysis

  1 day

• Blood sampling and biochemical analysis

  2 hours

Study Arms (2)

Roller pump group

OTHER

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.

Diagnostic Test: vascular reactivity of internal thoracic arteries

Centrifugal pump group

OTHER

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.

Diagnostic Test: vascular reactivity of internal thoracic arteries

Interventions

vascular reactivity of internal thoracic arteries 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; Roller pump group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Related Publications (1)

• 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.

  PMID: 32645079 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The IPITA (Impact of Pumps on Internal Thoracic Arteries) study consisted of two parallel prospective, monocenter, randomized, active-treatment-controlled clinical trials

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 19, 2019
• Study Start: November 3, 2015
• Primary Completion: November 8, 2017
• Study Completion: December 8, 2017
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share