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OpenTrials
Completed

NCT Number: NCT05574621

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Inflammatory burden

    Time frame: through study completion, an average of 6 months

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

Secondary outcomes

  1. Oxidative stress

    Time frame: through study completion, an average of 6 months

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

Sponsors and collaborators

Lead sponsor

Cardiochirurgia E.H.

Other

Collaborators

  • Andrea Salica
  • Francesco Giosuè Irace
  • University of Roma La Sapienza

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 10, 2022
Registry last updated
Sep 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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