An interventional study of CorMatrix extra cellular matrix (ECM) in Coronary Artery Disease, sponsored by Inova Health Care Services. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-07.
Sponsored by Inova Health Care Services · Not applicable, Interventional, and Treatment
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).
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.
5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.
This study's enrollment of 44 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Inova Health Care Services is the lead sponsor of 84 studies on the registry; 20 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
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Exclusion Criteria:
The treatment "Cormatrix" group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.
Device: CorMatrix extra cellular matrix (ECM)
The control "No Intervention" group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care.
* 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.
Also known as: CorMatrix ECM, CorMatrix, ECM
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.
Time frame: Baseline and and Post-Op day 3
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
Time frame: Up to 30 days post surgery
| Milestone | CorMatrix Group | Control |
|---|---|---|
| Started | 22 | 22 |
| Completed | 20 | 20 |
| Not completed | 2 | 2 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Data collection error | 1 | 1 |
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.
| Percent Change | CorMatrix Group | Control |
|---|---|---|
| IL6 (Interleukin 6) | 645 ± 400 | 767 ± 380 |
| IL8 (Interleukin 8) | 44 ± 2 | 28 ± 16 |
| IL2R (Interleukin 2 Receptor) | 35 ± 29 | 31 ± 25 |
| TNF (Tumor Necrosis Factor) | 5 ± 3 | 7 ± 5 |
| LBP (Lipopolysaccharide Binding Protein) | 190 ± 45 | 197 ± 57 |
Number of patients that were determined to have Post Operative Atrial Fibrillation by electrocardiograph within 30 days of surgery
| Participants | CorMatrix Group | Control |
|---|---|---|
| Occurrences of Post Operative Atrial Fibrillation (POAF) | 2 | 0 |
Collected over Up to 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CorMatrix Group | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Control | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | CorMatrix Group | Control | Total |
|---|---|---|---|
| Mean | 61.18 ± 9.88 | 60.17 ± 9.84 | 60.30 ± 9.93 |
| Sex: Female, Male(Participants) | CorMatrix Group | Control | Total |
|---|---|---|---|
| Female | 3 | 2 | 5 |
| Male | 17 | 18 | 35 |
| Region of Enrollment(participants) | CorMatrix Group | Control | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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