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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
Sponsor:
Collaborator:
CorMatrix Cardiovascular, Inc.
Information provided by (Responsible Party):
Inova Health Care Services

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Coronary Artery Disease
Intervention Device: CorMatrix extra cellular matrix (ECM)
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CorMatrix Group Control
Hide Arm/Group Description

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.

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
Started 22 22
Completed 20 20
Not Completed 2 2
Reason Not Completed
Withdrawal by Subject             1             1
Data collection error             1             1
Arm/Group Title CorMatrix Group Control Total
Hide Arm/Group Description

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.

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 Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
61.18  (9.88) 60.17  (9.84) 60.30  (9.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
3
  15.0%
2
  10.0%
5
  12.5%
Male
17
  85.0%
18
  90.0%
35
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Inflammatory Biomarkers
Hide Description
  • 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.
Time Frame Blood and Pericardial Fluid Baseline draw. Pericardial Fluid Post-Op Draw. Blood Post-Op draw Day 1 and Day 3.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CorMatrix Group Control
Hide Arm/Group Description:

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.

The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
Porcine proteins in pericardial fluid 0 0
Elevated pro-inflammatory proteins in blood 20 20
2.Secondary Outcome
Title Post Operative Atrial Fibrillation
Hide Description Post operative rhythm during hospital stay. Rhythm on discharge. Rhythm at cardiac surgery visit. Rhythm within 30 days of surgery.
Time Frame Within 30 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CorMatrix Group Control
Hide Arm/Group Description

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.

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 Group Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
CorMatrix Group Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
CorMatrix Group Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
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
Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT01535807     History of Changes
Other Study ID Numbers: CorMatrix ECM Study
First Submitted: February 15, 2012
First Posted: February 20, 2012
Results First Submitted: November 19, 2015
Results First Posted: December 24, 2015
Last Update Posted: December 24, 2015