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

Sponsor
Inova Health Care Services (Other)
Overall Status
Terminated
CT.gov ID
NCT01535807
Collaborator
CorMatrix Cardiovascular, Inc. (Industry)
44
Enrollment
1
Location
2
Arms
53
Actual Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or DiseaseIntervention/TreatmentPhase
  • Device: CorMatrix extra cellular matrix (ECM)
N/A

Detailed Description

The pericardium's main function is to secrete proteins that ensure proper functioning within the pericardial space and to maintain pericardial pressure. Once dissected the pericardium is usually left open at the end of surgery due to the difficulty in realigning the edges and to avoid adverse effects cause by an inflammatory response. The body's inflammatory response is one of protection and healing of an injury. However many of the inflammatory biomarkers released can cause adverse outcomes after cardiac surgery, including: renal failure, myocardial infarction, atrial fibrillation, stroke and death.

CorMatrix extra cellular matrix (ECM) Technology is a Food and Drug Administration (FDA) approved unique extra cellular implant material used for pericardial closure and reconstruction. Pericardial reconstruction using porcine intestinal ECM is a novel application. ECM combines the innate attributes of nature with the precision of science to help the heart heal itself. It is an acellular biomaterial that does not encapsulate when surgically implanted, but is gradually remodeled, leaving behind organized and healthy tissue. The body's tissue begins remodeling at the surgical site while the ECM maintains the needed tissue support. When implanted, the ECM acts as a scaffold into which the patient's cells migrate and integrate, stimulating the patient's natural wound-healing mechanisms. As the patient's cells become active, they lay down their own collagen, which matures over time to form strong and permanent tissue repair without leaving behind permanent foreign material. Because the ECM contains primarily collagen, the device is gradually replaced as the patient's tissue gradually turns over in a natural state of self-renewal.

A retrospective study compared the incidence of post operative atrial fibrillation (POAF) in patients treated with the CorMatrix ECM for pericardial closure following isolated coronary artery bypass graft (CABG) versus patients not treated with the patch. The retrospective study comprised of 222 patients. 111 were treated with the CorMatrix ECM and the other 111 were not. Results showed POAF in 34 of 111 control patients but only 20 in 111 CorMatrix ECM treated patients, indicating a 54% decrease in the risk of POAF in the CorMatrix ECM treated patients. This study shows a statistically significant reduction in the risk of POAF in patients undergoing an isolated CABG with pericardial closure using the CorMatrix ECM.

This is an unblinded, randomized study 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). The study will be located at the Inova Heart and Vascular Institute (IHVI). The CorMatrix ECM will be implanted during the CABG surgical procedure in the IHVI cardiovascular operating rooms (CVOR).

Sixty (60) patients who are routinely scheduled for a CABG will be recruited and randomly assigned to one of the two groups. There will be thirty (30) patients in each group. The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care. The treatment "Cormatrix" group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.

Pericardial fluid and blood samples will be collected from all patients. Pericardial fluid and blood samples will undergo novel nanoparticle based biomarker discovery technology to harvest proteomic biomarkers at the George mason University. In addition, patients will have their cardiac rhythm continually assessed during their hospital stay and then at their follow up appointments with their surgeon and cardiologist to determine whether they developed POAF post discharge.

Both genders, greater than eighteen (18) years of age, will be included in the research. There are no enrollment restrictions based upon race or ethnic origin and it is expected their inclusion will be representative of the population undergoing CABG at IHVI. Pregnant women are excluded from the study.

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CorMatrix ECM Study: To Identify Inflammatory Markers Following CABG With/Without CorMatrix's Extra Cellular Matrix (ECM)
Actual Study Start Date :
Jan 1, 2012
Actual Primary Completion Date :
Feb 1, 2013
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

ArmIntervention/Treatment
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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Inflammatory Biomarkers [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.

    Secondary Outcome Measures

    1. Post Operative Atrial Fibrillation [Within 30 days]

      Post operative rhythm during hospital stay. Rhythm on discharge. Rhythm at cardiac surgery visit. Rhythm within 30 days of surgery.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    SiteCityStateCountryPostal Code
    1Inova Heart and Vascular InstituteFalls ChurchVirginiaUnited States22042

    Sponsors and Collaborators

    • Inova Health Care Services
    • CorMatrix Cardiovascular, Inc.

    Investigators

    • Principal Investigator: Niv Ad, MD, Inova Health Systems

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Inova Health Care Services
    ClinicalTrials.gov Identifier:
    NCT01535807
    Other Study ID Numbers:
    • CorMatrix ECM Study
    First Posted:
    Feb 20, 2012
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleCorMatrix GroupControl
    Arm/Group DescriptionThe treatment "Cormatrix" group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique. 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.The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
    Period Title: Overall Study
    STARTED2222
    COMPLETED2020
    NOT COMPLETED22

    Baseline Characteristics

    Arm/Group TitleCorMatrix GroupControlTotal
    Arm/Group DescriptionThe treatment "Cormatrix" group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique. 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.The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.Total of all reporting groups
    Overall Participants202040
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    61.18
    (9.88)
    60.17
    (9.84)
    60.30
    (9.93)
    Sex: Female, Male (Count of Participants)
    Female
    3
    15%
    2
    10%
    5
    12.5%
    Male
    17
    85%
    18
    90%
    35
    87.5%
    Region of Enrollment (participants) [Number]
    United States
    20
    100%
    20
    100%
    40
    100%

    Outcome Measures

    1. Primary Outcome
    TitleInflammatory Biomarkers
    DescriptionThe 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.
    Time FrameBlood and Pericardial Fluid Baseline draw. Pericardial Fluid Post-Op Draw. Blood Post-Op draw Day 1 and Day 3.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group TitleCorMatrix GroupControl
    Arm/Group DescriptionThe treatment "Cormatrix" group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique. 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.The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
    Measure Participants2020
    Porcine proteins in pericardial fluid
    0
    0%
    0
    0%
    Elevated pro-inflammatory proteins in blood
    20
    100%
    20
    100%
    2. Secondary Outcome
    TitlePost Operative Atrial Fibrillation
    DescriptionPost operative rhythm during hospital stay. Rhythm on discharge. Rhythm at cardiac surgery visit. Rhythm within 30 days of surgery.
    Time FrameWithin 30 days

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group TitleCorMatrix GroupControl
    Arm/Group DescriptionThe treatment "Cormatrix" group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique. 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.The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
    All Cause Mortality
    CorMatrix GroupControl
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total/ (NaN) / (NaN)
    Serious Adverse Events
    CorMatrix GroupControl
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/20 (0%) 0/20 (0%)
    Other (Not Including Serious) Adverse Events
    CorMatrix GroupControl
    Affected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/20 (0%) 0/20 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleLisa Fornaresio, PhD
    OrganizationInova Heart and Vascular Institute
    Phone703-776-7071
    Emaillisa.fornaresio@inova.org
    Responsible Party:
    Inova Health Care Services
    ClinicalTrials.gov Identifier:
    NCT01535807
    Other Study ID Numbers:
    • CorMatrix ECM Study
    First Posted:
    Feb 20, 2012
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021