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

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: November 19, 2015
Last verified: November 2015
Results First Received: November 19, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Coronary Artery Disease
Intervention: Device: CorMatrix extra cellular matrix (ECM)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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.

Control The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.

Participant Flow:   Overall Study
    CorMatrix Group   Control
STARTED   22   22 
COMPLETED   20   20 
NOT COMPLETED   2   2 
Withdrawal by Subject                1                1 
Data collection error                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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.

Control The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
Total Total of all reporting groups

Baseline Measures
   CorMatrix Group   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.18  (9.88)   60.17  (9.84)   60.30  (9.93) 
Gender 
[Units: Participants]
     
Female   3   2   5 
Male   17   18   35 
Region of Enrollment 
[Units: Participants]
     
United States   20   20   40 


  Outcome Measures

1.  Primary:   Inflammatory Biomarkers   [ Time Frame: Blood and Pericardial Fluid Baseline draw. Pericardial Fluid Post-Op Draw. Blood Post-Op draw Day 1 and Day 3. ]

2.  Secondary:   Post Operative Atrial Fibrillation   [ Time Frame: Within 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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/Title: Lisa Fornaresio, PhD
Organization: Inova Heart and Vascular Institute
phone: 703-776-7071
e-mail: lisa.fornaresio@inova.org



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
Results First Received: November 19, 2015
Last Updated: November 19, 2015
Health Authority: United States: Institutional Review Board