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

NCT01535807 | Terminated Results

• 1 other identifier: CorMatrix ECM Study
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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).

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and and Post-Op day 3

Secondary Outcomes (1)

• Occurrences of Post Operative Atrial Fibrillation (POAF)

  Up to 30 days post surgery

Study Arms (2)

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.

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.

Interventions

CorMatrix extra cellular matrix (ECM) DEVICE

* 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

CorMatrix Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Inova Health Care Services: lead
• Corvivo Cardiovascular, Inc.: collaborator

Study Sites (1)

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

Related Links

• ECM Technologies by CorMatrix

MeSH Terms

Conditions

Coronary Artery Disease; Atrial Fibrillation; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Necrosis

Results Point of Contact

• Title: Lisa Fornaresio, PhD
• Organization: Inova Heart and Vascular Institute

lisa.fornaresio@inova.org

703-776-7071

Study Officials

• Niv Ad, MD

  Inova Health Systems

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2012
• First Posted: February 20, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: June 1, 2016
• Last Updated: November 7, 2022
• Results First Posted: December 24, 2015

Record last verified: 2022-11

Locations

US (1)