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ITA Vs LAD; Evaluation of Inflammatory Burden in OP-CABG Patients

Sponsor
Cardiochirurgia E.H. (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05574621
Collaborator
University of Roma La Sapienza (Other), Andrea Salica (Other), Francesco Giosuè Irace (Other)
40
Enrollment
1
Location
18
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Introduction. Ischemic cardiomyopathy is one of the death leading causes in industrialized countries. Up-to-date ESC guidelines recommend a surgical approach (coronary by pass graft) in patients with multivessel coronaropathy, with involvement of left main (LM) or proximal left anterior descending (LAD) artery. In any case, is recommended the use of the internal thoracic artery (ITA) as conduct of choice.

In consideration of the very strong evidence supporting the use of ITA, the study objective is to analyze and compare some blood markers collected from ITA blood vs. LAD blood, with the purpose of better understanding the technique benefits from a biological point of view, being the hemodynamic one already evident.

Methods. Forty patients scheduled for coronary bypass graft (CABG) surgery at the Cardiac Surgery Unit of European Hospital of Rome will be enrolled. Patients which intervention includes off-pump ITA-LAD anastomosis will be included. For each patient blood sample from ITA and LAD will be collected. On those samples, polymorphonuclear leukocytes and platelets activity, endothelial dysfunction, oxidative stress and inflammatory burden will be analysed. In patients in which a pre-operative coronary CT scan is available, findings will be correlated with atherosclerotic plaque morphology.

Expected results. Diseased LAD's blood will have a deranged markers profile compared with ITA's, with augmented inflammatory burden, reduce NO availability and increased platelet activation. In the patients subgroup with available coronary CT scan will be possible to esteem the effective blood mixing and speculate on a possible pharmacological effect of CABG, in terms of dilution of inflammatory burden in the target vessel.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Comparison of Inflammatory Markers, Oxidative Stress, Platelet Activation and Autophagy Between Internal Thoracic Artery and Left Anterior Descending Artery in Patients Subjected to Off-pump Surgical Myocardial Revascularization
    Actual Study Start Date :
    Jul 1, 2021
    Actual Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Inflammatory burden [through study completion, an average of 6 months]

      Serum inflammatory cytokines, evaluated through enzyme-linked immunosorbent assays (ELISA)

    Secondary Outcome Measures

    1. Oxidative stress [through study completion, an average of 6 months]

      soluble NOX-derived peptide evaluated through ELISA; H2O2 evaluated with colorimetric test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Scheduled coronary bypass surgery

    • Off-pump procedure

    • ITA-LAD anastomosis

    Exclusion Criteria:

    • STEMI in the last month

    • LVEF > 30%

    • LAD chronic occlusion

    • Acute or chronic inflammatory diseases

    • Immunologic or rheumatic diseases

    • Oncologic condition (present or in the last 3 years)

    • Active infections

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 European Hospital Rome Italy 00100

    Sponsors and Collaborators

    • Cardiochirurgia E.H.
    • University of Roma La Sapienza
    • Andrea Salica
    • Francesco Giosuè Irace

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cardiochirurgia E.H.
    ClinicalTrials.gov Identifier:
    NCT05574621
    Other Study ID Numbers:
    • EH2021-01
    First Posted:
    Oct 10, 2022
    Last Update Posted:
    Oct 10, 2022
    Last Verified:
    Oct 1, 2022
    Keywords provided by Cardiochirurgia E.H.
    coronary artery bypass graft
    coronary revascularization
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Heart Diseases
    Atherosclerosis
    Inflammation

    Study Results

    No Results Posted as of Oct 10, 2022