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Trial Outcomes & Findings for CorMatrix ECM Study: To Identify Inflammatory Markers Following CABG With/Without ECM (NCT NCT01535807)

NCT ID: NCT01535807

Last Updated: 2022-11-07

Results Overview

Percentage change in Inflammatory Cytokine Levels in serum derived from participant blood sample that underwent novel nanoparticle-based biomarker harvesting technology to capture and isolate global low molecular weight (LMW) proteome. Peptides from captured proteomes are detected with reversed-phase liquid chromatography/electrospray tandem mass spectrometry (LC-MS/MS). Inflammatory cytokines include Interleukin 6 (IL6), Interleukin 8 (IL8), Interleukin 2 Receptor (IL2R), Tumor Necrosis Factor (TNF), and Lipopolysaccharide Binding Protein (LBP). The measure of their respective levels is defined here as the Spectral Count from LC-MS/MS analysis. Percentage change of Spectral Counts is the difference of Day 3 post-surgery and pre-surgical baseline relative to the pre-surgical baseline.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

Baseline and and Post-Op day 3

Results posted on

2022-11-07

Participant Flow

Participant milestones

Participant milestones
Measure
CorMatrix Group
The treatment "Cormatrix" group will receive the CorMatrix extra cellular matrix (ECM) during surgery for the closure of the pericardium according to the specific recommended surgical technique. CorMatrix 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.
Overall Study
STARTED
22
22
Overall Study
COMPLETED
20
20
Overall Study
NOT COMPLETED
2
2

Reasons for withdrawal

Reasons for withdrawal
Measure
CorMatrix Group
The treatment "Cormatrix" group will receive the CorMatrix extra cellular matrix (ECM) during surgery for the closure of the pericardium according to the specific recommended surgical technique. CorMatrix 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.
Overall Study
Withdrawal by Subject
1
1
Overall Study
Data collection error
1
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CorMatrix Group
n=20 Participants
The treatment "Cormatrix" group will receive the CorMatrix ECM 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
n=20 Participants
The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
Total
n=40 Participants
Total of all reporting groups
Age, Continuous
61.18 years
STANDARD_DEVIATION 9.88 • n=5 Participants
60.17 years
STANDARD_DEVIATION 9.84 • n=7 Participants
60.30 years
STANDARD_DEVIATION 9.93 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Sex: Female, Male
Male
17 Participants
n=5 Participants
18 Participants
n=7 Participants
35 Participants
n=5 Participants
Region of Enrollment
United States
20 participants
n=5 Participants
20 participants
n=7 Participants
40 participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and and Post-Op day 3

Percentage change in Inflammatory Cytokine Levels in serum derived from participant blood sample that underwent novel nanoparticle-based biomarker harvesting technology to capture and isolate global low molecular weight (LMW) proteome. Peptides from captured proteomes are detected with reversed-phase liquid chromatography/electrospray tandem mass spectrometry (LC-MS/MS). Inflammatory cytokines include Interleukin 6 (IL6), Interleukin 8 (IL8), Interleukin 2 Receptor (IL2R), Tumor Necrosis Factor (TNF), and Lipopolysaccharide Binding Protein (LBP). The measure of their respective levels is defined here as the Spectral Count from LC-MS/MS analysis. Percentage change of Spectral Counts is the difference of Day 3 post-surgery and pre-surgical baseline relative to the pre-surgical baseline.

Outcome measures

Outcome measures
Measure
CorMatrix Group
n=20 Participants
The treatment "Cormatrix" group will receive the CorMatrix ECM (Extra Cellular Matrix) during surgery for the closure of the pericardium according to the specific recommended surgical technique. CorMatrix 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
n=20 Participants
The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
Change in Inflammatory Cytokine Levels in Participant Sera From Pre-surgery Baseline to Day 3 Post-surgery.
IL6 (Interleukin 6)
645 Percent Change
Standard Error 400
767 Percent Change
Standard Error 380
Change in Inflammatory Cytokine Levels in Participant Sera From Pre-surgery Baseline to Day 3 Post-surgery.
IL8 (Interleukin 8)
44 Percent Change
Standard Error 2
28 Percent Change
Standard Error 16
Change in Inflammatory Cytokine Levels in Participant Sera From Pre-surgery Baseline to Day 3 Post-surgery.
IL2R (Interleukin 2 Receptor)
35 Percent Change
Standard Error 29
31 Percent Change
Standard Error 25
Change in Inflammatory Cytokine Levels in Participant Sera From Pre-surgery Baseline to Day 3 Post-surgery.
TNF (Tumor Necrosis Factor)
5 Percent Change
Standard Error 3
7 Percent Change
Standard Error 5
Change in Inflammatory Cytokine Levels in Participant Sera From Pre-surgery Baseline to Day 3 Post-surgery.
LBP (Lipopolysaccharide Binding Protein)
190 Percent Change
Standard Error 45
197 Percent Change
Standard Error 57

SECONDARY outcome

Timeframe: Up to 30 days post surgery

Number of patients that were determined to have Post Operative Atrial Fibrillation by electrocardiograph within 30 days of surgery

Outcome measures

Outcome measures
Measure
CorMatrix Group
n=20 Participants
The treatment "Cormatrix" group will receive the CorMatrix ECM (Extra Cellular Matrix) during surgery for the closure of the pericardium according to the specific recommended surgical technique. CorMatrix 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
n=20 Participants
The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
Occurrences of Post Operative Atrial Fibrillation (POAF)
2 Participants
0 Participants

Adverse Events

CorMatrix Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa Fornaresio, PhD

Inova Heart and Vascular Institute

Phone: 703-776-7071

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place