Clincosm LogoSign in Get a demo

SEX-HYBRID: Sex-related Differences in Outcome After Hybrid Coronary Revascularization

Sponsor
University of Roma La Sapienza (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06023355
Collaborator
(none)
1,000
Enrollment
16
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: HYBRID

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Sex-related Differences in Outcome After Hybrid Coronary Revascularization Versus Coronary Artery Bypass Grafting in Multivessel Coronary Artery Disease: The SEX-HYBRID Study
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2024

Outcome Measures

Primary Outcome Measures

  1. Incidence of Overall Mortality [Up to 1 year]

    All causes deaths

  2. Incidence of Composite End-point [Up to 1 year]

    Cardiac death, myocardial infarction, stroke, bleeding

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Patients with coronary artery disease and indication to cardiac surgery

Exclusion Criteria:

Contraindications to cardiac surgery

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Roma La Sapienza

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Francesco Pelliccia, Associate Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT06023355
Other Study ID Numbers:
  • 2023/D/1066
First Posted:
Sep 5, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease

Study Results

No Results Posted as of Sep 7, 2023