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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05574621
• Other study ID #: EH2021-01
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: September 2023
• Source: Cardiochirurgia E.H.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Heart Diseases
• Inflammation
• Ischemic Heart Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Italy	European Hospital	Rome

Sponsors (4)

Lead Sponsor	Collaborator
Cardiochirurgia E.H.	Andrea Salica, Francesco Giosuè Irace, University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory burden	Serum inflammatory cytokines, evaluated through enzyme-linked immunosorbent assays (ELISA)	through study completion, an average of 6 months
Secondary	Oxidative stress	soluble NOX-derived peptide evaluated through ELISA; H2O2 evaluated with colorimetric test	through study completion, an average of 6 months