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

Retrospective Observational Study of Patients Who Have Undergone Coronary Artery Bypass Graft (CABG) and/or Cardiac Valve Surgery: Post-discharge Follow-up of Patients From REN-004 Clinical Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07009340

Enrollment

200

Registered

2025-06-06

Start date

2023-11-18

Completion date

2025-06-30

Last updated

2025-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-discharge Outcomes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
Total estimated cost of in hospital and post-discharge	1 year

Countries

United States

Outcome results