Study of Role of Blood Microvescicles and Exosomes in Patients With Graft Occlusion After Aortocoronary Bypass Surgery (MVBYPASS)

Coronary artery bypass graft (CABG) surgery is still the standard treatment of coronary revascularization for patients with severe coronary artery disease (CAD). Graft patency, together with completeness of revascularization, is a major determinant of long-term outcome following CABG. The surgical procedure elicits a persistent systemic inflammatory response associated with the activation of the hemostatic system leading to perturbation of endothelial and vascular function and activation of platelets and leukocytes. All of these events are the main players responsible for the early and late graft failure in a significant percentage of patients.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Bypass Surgery

Detailed Description

Circulating microvesicles (MVs) have received increasing attention during the last years as novel players in cardiovascular disease. MVs are small membrane vesicles involved in cell-to-cell communication acting as biological messengers. MVs of different origin are present in the circulation of healthy subjects, and their number increases in several pathological conditions contributing to the development, progression, and clinical outcome of diseases. They have been proposed as biomarkers of thrombosis, vascular injury, and inflammation in atherothrombosis and myocardial infarction, where elevated levels have been correlated with disease severity. Among the circulating MVs, those expressing phosphatidylserine are defined as procoagulant MVs. A subgroup of procoagulant MVs also express tissue factor (TF), the key activator of the blood coagulation cascade. These procoagulant MVs have a role in the prediction of cardiovascular events and are able to identify patients at high recurrence risk. Thus far, many studies have generated compelling data on the sensitivity of circulating MVs as biomarkers of cardiovascular disease progression and events. The usefulness of MVs in patients undergoing CABG, however, has only been tested in 1 study that highlighted their importance in surgical hemostasis. No information is so far available on the association between the amount or pattern of circulating MVs and CABG outcome.Thus, we carried out this study to investigate potential functional role of MVs and exosomes in graft occlusion based on their protein profile as well as their procoagulant potentia.l

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Alberto Albertini, MD; Phone Number: +39 0545 217693; Email: aalbertini@gvmnet.it
• Study Contact Backup: Name: Elena Tenti; Email: etenti@gvmnet.it

Study Locations

• Italy
  • Ravenna
    • Cotignola, Ravenna, Italy, 48033
      • Recruiting
      • MCH
      • Contact: Alberto Albertini, MD; Email: aalbertini@gvmnet.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients undergoing elective CABG ( coronary artery bypass graft )

Description

Inclusion Criteria:

• between the ages of 40 and 80
• Ejection fraction> 30%
• coronary artery bypass surgery
• informed consent
• Willingness to carry out the follow-up visits and the assessments required by the protocol

Exclusion Criteria:

• emergency intervention
• changes in liver or kidney function
• changes in coagulation factors
• associated interventions (valve replacement, carotid endarterectomy)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Confirmation and validation of the potential role of blood MV and exosomes as predictors of bypass occlusions	from 15 to 21 months

Collaborators and Investigators

• Sponsor: Maria Cecilia Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 6, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MCH 2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No