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

Completed

• Conditions: Ischemic Heart Disease; Atherosclerosis; Inflammation; Coronary Artery Disease

• Registration Number: NCT05574621
• Lead Sponsor: Cardiochirurgia E.H.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2022-10-01
• Study First Submitted QC: 2022-10-07
• Study First Posted: 2022-10-10
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory burden	through study completion, an average of 6 months	Serum inflammatory cytokines, evaluated through enzyme-linked immunosorbent assays (ELISA)

Secondary Outcome Measures

Name	Time	Method
Oxidative stress	through study completion, an average of 6 months	soluble NOX-derived peptide evaluated through ELISA; H2O2 evaluated with colorimetric test

Trial Locations

Locations (1)

European Hospital; 🇮🇹 Rome, Italy