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

NCT05574621 | Completed

• 1 other identifier: EH2021-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Heart Disease; Coronary Artery Disease; Atherosclerosis; Inflammation

Keywords

coronary artery bypass graft; coronary revascularization

Outcome Measures

Primary Outcomes (1)

• Inflammatory burden

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

  through study completion, an average of 6 months

Secondary Outcomes (1)

• Oxidative stress

  through study completion, an average of 6 months

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited among the all-comers surgical candidates at European Hospital of Rome, which includes out patient clinic, internal transfers from cardiology unit, urgent transfers from other regional hospitals.

You may qualify if:

• Scheduled coronary bypass surgery
• Off-pump procedure
• ITA-LAD anastomosis

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

European Hospital

Rome, 00100, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood collected for internal thoracic artery and left descending artery

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease; Atherosclerosis; Inflammation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2022
• First Posted: October 10, 2022
• Study Start: July 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

IT (1)