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NCT Number: NCT05411445

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

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.

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Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

MCH

Cotignola, Ravenna, 48033, Italy

Location status: Recruiting

Location contact

Alberto Albertini, MD

CONTACT

[email protected]

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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

    Time frame: from 15 to 21 months

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Albertini, MD

CONTACT

[email protected]

+39 0545 217693

Elena Tenti

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Maria Cecilia Hospital

Other

Registry information

Acronym: MVBYPASS

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 9, 2022
Registry last updated
Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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