CorMatrix ECM Study: To Identify Inflammatory Markers Following CABG With/Without ECM (CorMatrix)
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|ClinicalTrials.gov Identifier: NCT01535807|
Recruitment Status : Unknown
Verified November 2015 by Inova Health Care Services.
Recruitment status was: Active, not recruiting
First Posted : February 20, 2012
Results First Posted : December 24, 2015
Last Update Posted : December 24, 2015
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: CorMatrix extra cellular matrix (ECM)||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CorMatrix ECM Study: To Identify Inflammatory Markers Following CABG With/Without CorMatrix's Extra Cellular Matrix (ECM)|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||February 2013|
|Estimated Study Completion Date :||June 2016|
Active Comparator: CorMatrix Group
The treatment "Cormatrix" group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.
Device: CorMatrix extra cellular matrix (ECM)
Other Name: CorMatrix ECM, CorMatrix, ECM
No Intervention: Control
The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
- Inflammatory Biomarkers [ Time Frame: Blood and Pericardial Fluid Baseline draw. Pericardial Fluid Post-Op Draw. Blood Post-Op draw Day 1 and Day 3. ]
- The identification of global low molecular weight (LMW) serum proteomic changes associated with CorMatrix ECM treated patients.
- Identification of porcine specific LMW and phosphoproteomic serum protein changes associated with CorMatrix ECM treated patients.
- Post Operative Atrial Fibrillation [ Time Frame: Within 30 days ]Post operative rhythm during hospital stay. Rhythm on discharge. Rhythm at cardiac surgery visit. Rhythm within 30 days of surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01535807
|United States, Virginia|
|Inova Heart and Vascular Institute|
|Falls Church, Virginia, United States, 22042|
|Principal Investigator:||Niv Ad, MD||Inova Health Systems|