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

NCT05411445 | Recruiting

• 1 other identifier: MCH 2022-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Bypass Surgery

Outcome Measures

Primary Outcomes (1)

• Confirmation and validation of the potential role of blood MV and exosomes as predictors of bypass occlusions

  from 15 to 21 months

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients undergoing elective CABG ( coronary artery bypass graft )

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Maria Cecilia Hospital: lead

Study Sites (1)

MCH

Cotignola, Ravenna, 48033, Italy

RECRUITING

Central Study Contacts

Alberto Albertini, MD

CONTACT

+39 0545 217693; aalbertini@gvmnet.it

Elena Tenti

CONTACT

etenti@gvmnet.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 9, 2022
• Study Start: June 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)