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Coronary DiseaseIPITANCT04168853

Impact of Pumps on Internal Thoracic Arteries (IPITA)

A study testing vascular reactivity of internal thoracic arteries in people with Coronary Disease, run by University Hospital, Angers.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Coronary Disease
What is being tested?
vascular reactivity of internal thoracic arteries
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
3 Nov 2015to 8 Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

About this study

Official title: Cardiopulmonary Bypass and Internal Thoracic Arteries: Can Roller or Centrifugal Pumps Change Vascular Reactivity of the Grafts

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.

Read the 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.

Being tested
vascular reactivity of internal thoracic arteries
Keywords
cardiopulmonary bypass, pulsatility, systemic inflammatory response, arterial graft
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vascular reactivity of internal thoracic arteriesDiagnostic 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
Study groups in NCT04168853
Study groupRoleWhat they receive
Roller pump groupOtherCABG 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.
Receives: Diagnostic Test: vascular reactivity of internal thoracic arteries
Centrifugal pump groupOtherCABG 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.
Receives: Diagnostic Test: vascular reactivity of internal thoracic arteries

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 1 day

Secondary outcomes (4)

  1. Superoxide detection and confocal microscopy

    : dihydroethidium staining (DHE, Sigma-Aldrich) was used to evaluate the in-situ levels of superoxide anions (O2-). DHE is permeable to cells and is oxidized by superoxide (O2-) to fluorescent products that are trapped by intercalation into the DNA. Sections (10 μm thickness) were incubated with DHE (1 μmol/L) in phosphate-buffered solution (PBS) and DAPI (4',6'-diamidino-2-phénulindole-Molecular probes, Invitrogen) for nuclear cells Fluorescent images of ethidium bromide were obtained using a confocal microscope (Nikon Eclipse TE2000S).

    Measured: 1 day

  2. Immunochemistry

    sections (10 μm thickness) of arteries were rehydrated by 500 μl of PBS during 10 minutes and fixated with 200 μl of paraformaldehyde (PFA) (pH = 7.4, room temperature) and then were rinsed by PBS. Permeabilization with 200 μl of PBS-BSA (Bovine Serum Albumin - Sigma) 10% - Tween 0.1% during 40 minutes and then saturation with PBS-BSA 10% during 40 minutes were performed. Sections were incubated overnight with 100 μl of anti-CD45 antibody at 1/500th dilution for leukocyte staining or anti-CD80 antibody at 1/200th dilution for lymphocyte staining. Antibodies were labelled with a red fluorochrome (Phycoerythrine). Karyoplasm was stained blue by DAPI solution. On day+1, sections were rinsed with PBS and analyzed with the confocal microscope. Fluorescent images were quantified with the ImageJ (NIH) software.

    Measured: 1 day

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

    Sections of ITAs were dried and stored at -80°C in RNA later Stabilization Reagent (Qiagen). RNA extraction was performed using the RNeasy® micro kit (Qiagen). 500 ng of RNA extracted from each artery were used to synthesize cDNA using the QuantiTect® Reverse Transcription kit (Qiagen). Quantitative real-time PCR was performed with Sybr® Green PCR Master Mix (Applied Biosystems) using a Light cycler 480 Real-Time PCR System (Roche).

    Measured: 1 day

  4. Blood sampling and biochemical analysis

    Serial arterial blood samples for elastase and for SC5b-9, marker of terminal complement complex activation, were collected at Time 1 and Time 2. Specimens were centrifuged (10 minutes, 3,000 rpm, 4°C) immediately to obtain plasma which was stored at - 80°C before analysis.

    Enzyme-linked immunosorbent assay techniques were used from 10 μl of plasma to measure terminal complement (SC5b-9; Quidel, San Diego, CA, USA) and 50 μl of plasma for neutrophil elastase (Neutrophil ELA2, Assay pro, St Charles, USA). The limit of sensitivity of each assay undertaken was as follows: SC5b-9 = 16 ng/mL and elastase = 20 ng/mL.

    Measured: 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2019
  2. Study start3 Nov 2015
  3. Primary completion8 Nov 2017
  4. Study completion8 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
The IPITA (Impact of Pumps on Internal Thoracic Arteries) study consisted of two parallel prospective, monocenter, randomized, active-treatment-controlled clinical trials
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04168853
Sponsor's protocol ID
CHU Angers
Acronym
IPITA
Status last verified
Nov 2019
First submitted
14 Nov 2019
Last updated
21 Nov 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32645079

Questions about this trial

What is this clinical trial studying?

A study testing vascular reactivity of internal thoracic arteries in people with Coronary Disease, run by University Hospital, Angers.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Myography (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04168853, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2019.

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