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Extracellular Matrix Implant
CorMatrix ECM Study: To Identify Inflammatory Markers Following CABG With/Without ECM (CorMatrix Trial)
N/A
Waitlist Available
Led By Niv Ad, MD
Research Sponsored by Inova Health Care Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days post surgery
Awards & highlights
No Placebo-Only Group
Summary
The objective of this study is to identify proteomic inflammatory biomarkers to determine if there are differences in the biomarkers in patients who are treated using the CorMatrix ECM implant to close the pericardium and the patients whose pericardium is left open (the current standard of care).
Eligible Conditions
- Coronary Artery Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 30 days post surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days post surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Inflammatory Cytokine Levels in Participant Sera From Pre-surgery Baseline to Day 3 Post-surgery.
Secondary study objectives
Occurrences of Post Operative Atrial Fibrillation (POAF)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: CorMatrix GroupActive Control1 Intervention
The treatment "Cormatrix" group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.
Group II: ControlActive Control1 Intervention
The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
Find a Location
Who is running the clinical trial?
CorMatrix Cardiovascular, Inc.Industry Sponsor
4 Previous Clinical Trials
187 Total Patients Enrolled
Inova Health Care ServicesLead Sponsor
73 Previous Clinical Trials
22,368 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
81 Patients Enrolled for Coronary Artery Disease
Niv Ad, MDPrincipal InvestigatorInova Health Systems
6 Previous Clinical Trials
723 Total Patients Enrolled