CorMatrix ECM Study: To Identify Inflammatory Markers Following CABG With/Without ECM

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
CorMatrix Cardiovascular, Inc.
Information provided by (Responsible Party):
Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT01535807
First received: February 15, 2012
Last updated: February 19, 2014
Last verified: February 2014
  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 2015
Estimated Primary Completion Date: January 2015 (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)
  • Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.
  • No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535807

Locations
United States, Virginia
Inova Heart and Vascular Institute
Falls Church, Virginia, United States, 22042
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: February 19, 2014
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 September 16, 2014