CorMatrix ECM Study: To Identify Inflammatory Markers Following CABG With/Without ECM
This study is currently recruiting participants.
Verified May 2012 by Inova Health Care Services
Sponsor:
Inova Health Care Services
Collaborator:
CorMatrix Cardiovascular, Inc.
Information provided by (Responsible Party):
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT01535807
First received: February 15, 2012
Last updated: May 29, 2012
Last verified: May 2012
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease |
Device: CorMatrix extra cellular matrix (ECM) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CorMatrix ECM Study: To Identify Inflammatory Markers Following CABG With/Without CorMatrix's Extra Cellular Matrix (ECM) |
Resource links provided by NLM:
Further study details as provided by Inova Health Care Services:
Primary Outcome Measures:
- Inflammatory biomarkers [ Time Frame: Blood and Pericardial Fluid Baseline draw. Pericardial Fluid Post-Op Draw. Blood Post-Op draw Day 1 and Day 3. ] [ Designated as safety issue: No ]
- 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.
Secondary Outcome Measures:
- Post Operative Atrial Fibrillation [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]Post operative rhythm during hospital stay. Rhythm on discharge. Rhythm at cardiac surgery visit. Rhythm within 30 days of surgery.
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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: No Intervention
The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
|
Device: CorMatrix extra cellular matrix (ECM)
Other Name: CorMatrix ECM, CorMatrix, ECM
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject is ≥18 years of age
- Subject must be selected as a candidate for isolated Coronary Artery Bypass Graft (CABG) procedure
- Subject has a Left Ventricular Ejection Fraction (LVEF) of ≥30%
- Subject is able and willing to provide written informed consent and HIPAA authorization
- Subject has a life expectancy of at least one year
Exclusion Criteria:
- Subject is scheduled for other concomitant surgical procedures (carotid surgery included)
- Subject has a known hypersensitivity to porcine material
- Subject has a religious or cultural objection to the use of blood or porcine products
- Subject is scheduled for Off Pump Coronary Artery Bypass procedures (OPCAB)
- Subject has a history of diagnosed treated or un-treated pre-operative atrial fibrillation or any other type of cardiac arrhythmia
- Subject has a history of anti-arrhythmic drug treatment in the past six (6) months
- Subject has an implantable cardiac device (e.g., pacemakers, implantable cardioverter defibrillators)
- Subject has a history of an accessory pathway disorder (e.g., Wolff-Parkinson-White syndrome)
- Subject has a documented myocardial infarction (MI) within six (6) weeks prior to study enrollment
- Subject needs emergent cardiac surgery (i.e., cardiogenic shock)
- Subject requires intra-aortic balloon pump or intravenous inotropes
- Subject has had an infection within six (6) weeks preceding surgery requiring antibiotic therapy
- Subject is on pre-surgical immunosuppressive therapy (corticosteroids included)
- Subject has chronic inflammatory disease (leukemia, lymphoma, arthritis, rheumatoid, lupus, Crohn's disease, ulcerative colitis, hepatitis C, HIV)
- Subject has had therapeutic radiation to the pericardium, either prior to surgery or expected during the three (3) week period following surgery
- There is an inability to approximate the graft and pericardium edge along the entire extent of the defect
- Subject is incarcerated
- Subject is participating in concomitant research studies of investigational products (e.g., Appendage closure devices, septal defect patches)
- Subject is unable to provide informed consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01535807
Contacts
| Contact: Lisa Martin, PhD | (703) 776-7071 | Lisa.Martin@inova.org |
| Contact: Abigail Roots | (703) 776-7011 | Abigail.Roots@inova.org |
Locations
| United States, Virginia | |
| Inova Heart and Vascular Institute | Recruiting |
| Falls Church, Virginia, United States, 22042 | |
| Contact: Lisa Martin, PhD 703-776-7071 Lisa.Martin@inova.org | |
| Contact: Abigail Roots (703) 776-7011 Abigail.Roots@inova.org | |
| Principal Investigator: Niv Ad, MD | |
Sponsors and Collaborators
Inova Health Care Services
CorMatrix Cardiovascular, Inc.
Investigators
| Principal Investigator: | Niv Ad, MD | Inova Health Systems |
More Information
Additional Information:
No publications provided
| Responsible Party: | Inova Health Care Services |
| ClinicalTrials.gov Identifier: | NCT01535807 History of Changes |
| Other Study ID Numbers: | CorMatrix ECM Study |
| Study First Received: | February 15, 2012 |
| Last Updated: | May 29, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Inova Health Care Services:
|
Atrial Fibrillation Cardiac surgery Coronary Artery Bypass Graft CorMatrix extra cellular matrix |
Heart surgery Inflammatory Biomarkers Myocardial Infarction identify proteomic inflammatory biomarkers |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013