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

Coronary Artery Bypass Surgery Clinical Trial

— MVBYPASS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411445
• Other study ID #: MCH 2022-01
• Status: Recruiting
• Start date: June 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: June 2023
• Source: Maria Cecilia Hospital
• Contact: Alberto Albertini, MD
• Phone: +39 0545 217693
• Email: aalbertini[@]gvmnet.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Bypass Surgery

Locations

Country	Name	City	State
Italy	MCH	Cotignola	Ravenna

Sponsors (1)

Lead Sponsor	Collaborator
Maria Cecilia Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confirmation and validation of the potential role of blood MV and exosomes as predictors of bypass occlusions		from 15 to 21 months