Prognostic Indices of Atheromatosis Severity and Coronary Artery Bypass Surgery Outcomes for Patients With Coronary Artery Disease

NCT06242171 | Active Not Recruiting

• 1 other identifier: 697/20.10.2020
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Coronary artery disease is a multifactorial disease. Traditional risk factors, such as obesity, diabetes, hypertension, stimulate the onset of an inflammatory process in the prone vessel and perivascular adipose tissue, which has not yet been clarified and is still being investigated. Coronary artery bypass grafting is an effective treatment of coronary artery disease, which has been shown to prolong survival. Perioperative analysis of the myocardial metabolic profile helps to identify appropriate markers and metabolites associated with early myocardial damage. This, in turn, helps to improve risk stratification by better understanding the mechanisms of the disease processes, in order to prevent postoperative myocardial infarction and its associated complications. Such indicators, which are related to the diagnosis and severity of coronary artery disease, as well as the prognosis of coronary artery bypass grafting, have been separately studied before, in the peripheral blood of patients with coronary artery disease, in healthy vascular tissues, such as mammary artery, compared to atherosclerotic tissue from the coronary artery, as well as in the epicardial adipose tissue, intraoperatively. The aim of the proposed study is to investigate and evaluate metabolic factors and biomarkers preoperatively, intraoperatively and postoperatively, in patients undergoing coronary artery bypass grafting and their prognostic value regarding a) the severity of coronary artery disease (Gensini score, ejection fraction, acute coronary syndrome) and b) the outcome of surgery (indications of myocardial damage and / or infarction, low cardiac output syndrome and use of intraortic balloon pump, atrial fibrillation, 30-day mortality).

Conditions

Coronary Artery Disease; Atheromatosis

Keywords

coronary sinus sampling; coronary artery bypass graft surgery

Outcome Measures

Primary Outcomes (1)

• Metabolic and molecular indices identified in coronary sinus and peripheral blood, as well as in epicardial, coronary artery and internal mammary artery tissue

  Correlation of the indices identified/ calculated with coronary artery disease severity and CABG outcome

  3 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients that are scheduled to have coronary artery bypass graft surgery in Onassis Cardiac Surgery Centre

You may not qualify if:

• Severe comorbidities; renal or liver failure, severe autoimmune disease Combined surgical procedures (valve surgery, aortic procedures, carotid surgery)

Sponsors & Collaborators

• Onassis Cardiac Surgery Centre: lead

Study Sites (1)

Onassis Cardiac Surgery Centre

Kallithea, Attica, 17674, Greece

Location

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Konstantinos Perreas, MD, PhD

  Onassis Cardiac Surgery Centre

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 5, 2024
• Study Start: October 30, 2020
• Primary Completion: August 31, 2021
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 5, 2024

Record last verified: 2024-01

Locations

GR (1)