Coronary Artery DiseaseCorMatrixNCT01535807
CorMatrix ECM Study: To Identify Inflammatory Markers Following CABG With/Without ECM
A study testing CorMatrix extra cellular matrix (ECM) in people with Coronary Artery Disease, run by Inova Health Care Services at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CorMatrix extra cellular matrix (ECM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042
About this study
Official title: CorMatrix ECM Study: To Identify Inflammatory Markers Following CABG With/Without CorMatrix's Extra Cellular Matrix (ECM)
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).
Read the 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 ECM 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.
- Conditions
- Coronary Artery Disease
- Being tested
- CorMatrix extra cellular matrix (ECM)
- Keywords
- Atrial Fibrillation, Cardiac surgery, Coronary Artery Bypass Graft, CorMatrix extra cellular matrix, Heart surgery, Inflammatory Biomarkers, Myocardial Infarction, identify proteomic inflammatory biomarkers
- Medical subject headings
- Coronary Artery Disease, Atrial Fibrillation, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorMatrix extra cellular matrix (ECM)Device
Also called CorMatrix ECM, 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.
| Study group | Role | What they receive |
|---|---|---|
| CorMatrix Group | Active comparator | The treatment "Cormatrix" group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique. Receives: Device: CorMatrix extra cellular matrix (ECM) |
| Control | No intervention | The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Inflammatory Cytokine Levels in Participant Sera From Pre-surgery Baseline to Day 3 Post-surgery.
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.
Measured: Baseline and and Post-Op day 3
Secondary outcomes (1)
Occurrences of Post Operative Atrial Fibrillation (POAF)
Number of patients that were determined to have Post Operative Atrial Fibrillation by electrocardiograph within 30 days of surgery
Measured: Up to 30 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionFeb 2013
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- Corvivo Cardiovascular, Inc.
- Responsible party
- Sponsor
- Investigators
- Niv Ad, MD, Principal investigator, Inova Health Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535807
- Sponsor's protocol ID
- CorMatrix ECM Study
- Acronym
- CorMatrix
- Status last verified
- Nov 2022
- First submitted
- 15 Feb 2012
- Last updated
- 7 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CorMatrix ECM Study: To Identify Inflammatory Markers Following CABG With/Without CorMatrix's Extra Cellular Matrix (ECM)
- ClinicalTrials.gov ID
- NCT01535807
- Acronym / sponsor ID
- CorMatrix / CorMatrix ECM Study
- Conditions
- Coronary Artery Disease
- Keywords
- Atrial Fibrillation, Cardiac surgery, Coronary Artery Bypass Graft, CorMatrix extra cellular matrix, Heart surgery, Inflammatory Biomarkers, Myocardial Infarction, identify proteomic inflammatory biomarkers
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Collaborators
- Corvivo Cardiovascular, Inc.
- Study start
- Jan 2012 (actual)
- Primary completion
- Feb 2013 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Feb 2012 (estimated)
- Results
- Posted 24 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 ECM 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CorMatrix Group | Active comparator | Device: CorMatrix extra cellular matrix (ECM)The treatment "Cormatrix" group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique. |
| Control | No intervention | –The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CorMatrix extra cellular matrix (ECM)Also: CorMatrix ECM, 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. | Device | CorMatrix Group |
Primary outcome
Change in Inflammatory Cytokine Levels in Participant Sera From Pre-surgery Baseline to Day 3 Post-surgery.
Time frame: 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.
1 secondary outcome
Occurrences of Post Operative Atrial Fibrillation (POAF)
Time frame: Up to 30 days post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- ECM Technologies by CorMatrixLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niv Ad, MD principal investigator
Inova Health Systems
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CorMatrix extra cellular matrix (ECM) in people with Coronary Artery Disease, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inflammatory Cytokine Levels in Participant Sera From Pre-surgery Baseline to Day 3 Post-surgery. (time frame: Baseline and and Post-Op day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.