Sex-related Differences in Outcome After Hybrid Coronary Revascularization

NCT ID: NCT06023355

Last Updated: 2023-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-12-31

Brief Summary

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Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional coronary artery bypass grafting (CABG) in a select group of patients with multivessel coronary artery disease (CAD). Till date, multiple individual studies comparing HCR with CABG have been carried out, but no data on the potential impact of sex on the outcome of HCR exist.

To fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent HCR or CABG.

Detailed Description

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Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional coronary artery bypass grafting (CABG) in a select group of patients with multivessel coronary artery disease (CAD).

Till date, multiple individual studies comparing HCR with CABG have been carried out, but no data on the potential impact of sex on the outcome of HCR exist. Limited by their sample size, these individual studies may have been under-powered to detect a difference.

To fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent HCR or CABG.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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HYBRID

It involves the combination of a sternal sparing left internal mammary artery (LIMA) bypass and percutaneous coronary intervention (PCI) with drug-eluting stents (DES) for non-left anterior descending (LAD) lesions. Through minimally invasive surgical techniques, HCR carries the potential for faster recovery postoperatively, fewer in-hospital complications, and lower utilization of healthcare resources, while providing the key benefits of LIMA-LAD grafting.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients with coronary artery disease and indication to cardiac surgery

Exclusion Criteria

Contraindications to cardiac surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Francesco Pelliccia

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Francesco Pelliccia

Role: CONTACT

Phone: +390633062615

Email: [email protected]

Fabio Miraldi

Role: CONTACT

Phone: +390633062615

Email: [email protected]

Other Identifiers

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2023/D/1066

Identifier Type: -

Identifier Source: org_study_id