Retrospective Observational Study of Patients Who Have Undergone Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery

Active, not recruiting

• Conditions: Post-discharge Outcomes

• Registration Number: NCT07009340
• Lead Sponsor: Renibus Therapeutics, Inc.

Brief Summary

This study is a retrospective chart abstraction for subjects who were enrolled in REN-004. As a retrospective study, all data will be abstracted from the medical records.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-18
• Study First Submitted: 2025-05-29
• Study First Submitted QC: 2025-05-29
• Status Verified: 2025-06
• Study First Posted: 2025-06-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patient completed REN-004
• Patient has at least 1 year of follow documentation post-discharge

Exclusion Criteria

• Patient enrolled in a clinical trial within 1-year post-discharge from REN-004

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-discharge outcomes for patients enrolled in REN-004 from one study center	1 year	Readmission for any reason Rehospitalization related to procedure/valve/heart failure Contacts with HCP post discharge (any HCP) PCP (if available) All tests and procedures post discharge Medications Chronic kidney disease (CKD) - new diagnosis Acute kidney injury (AKI) requiring dialysis Chronic Kidney disease (CKD) requiring dialysis Atrial fibrillation - new-onset Myocardial infarction (MI) Non-fatal cardiac arrest Reoperation for coronary artery bypass graft (CABG) Reoperation for valve dysfunction Stroke Death from any cause MACCE Death from any cause, repeat revascularization (CABG or PCI), non-fatal MI, and stroke

Secondary Outcome Measures

Name	Time	Method
Total estimated cost of in hospital and post-discharge	1 year

Trial Locations

Locations (4)

Heart Center Research, LLC; 🇺🇸 Huntsville, Alabama, United States

Lutheran Medical Center; 🇺🇸 Fort Wayne, Indiana, United States

My Michigan Medical Center; 🇺🇸 Midland, Michigan, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States