Clinical trial NCT05574621: ITA Vs LAD; Evaluation of Inflammatory Burden in OP-CABG Patients
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Heart Disease
Coronary Artery Disease
Atherosclerosis
Inflammation
Keywords: coronary artery bypass graft
coronary revascularization
Lead sponsor: Cardiochirurgia E.H.
Sponsor class: OTHER
Collaborators: name: University of Roma La Sapienza
name: Andrea Salica
name: Francesco Giosuè Irace
First posted: 2022-10-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Inflammatory burden
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Oxidative stress
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: European Hospital
Study officials:
References: