- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06023355
Sex-related Differences in Outcome After Hybrid Coronary Revascularization (SEX-HYBRID)
Sex-related Differences in Outcome After Hybrid Coronary Revascularization Versus Coronary Artery Bypass Grafting in Multivessel Coronary Artery Disease: The SEX-HYBRID Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Francesco Pelliccia
- Phone Number: +390633062615
- Email: f.pelliccia@mclink.it
Study Contact Backup
- Name: Fabio Miraldi
- Phone Number: +390633062615
- Email: f.pelliccia@mclink.it
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Patients with coronary artery disease and indication to cardiac surgery
Exclusion Criteria:
Contraindications to cardiac surgery
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Overall Mortality
Time Frame: Up to 1 year
|
All causes deaths
|
Up to 1 year
|
Incidence of Composite End-point
Time Frame: Up to 1 year
|
Cardiac death, myocardial infarction, stroke, bleeding
|
Up to 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023/D/1066
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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