Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-28 @ 2:14 PM
Study NCT ID:
NCT02887768
Status:
COMPLETED
Last Update Posted:
2017-10-30
First Post:
2016-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epicardial Infarct Repair Using CorMatrix®-ECM: Clinical Feasibility Study
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
Cardiac Infarct Repair Using CorMatrix®-ECM: Clinical Feasibility Study
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EIR
Brief Summary:
Epicardial Infarct Repair with CorMatrix-Extracellular Matrix (ECM) is an open-label, non-randomized, feasibility pilot study. Following ischemic injury the ECM of the heart adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and subsequent heart failure. Preclinical evidence demonstrates that epicardial infarct repair with CorMatrix-ECM restores the damaged ECM, prevents LV dilatation and improves myocardial performance. This study will interrogate epicardial infarct repair in patients undergoing coronary artery bypass grafting (CABG) surgery within 6 weeks following acute myocardial infarction as an adjunct to surgical revascularization. Patients will be evaluated for markers of cardiac function and left ventricular remodelling using cardiac magnetic resonance imaging (MRI). Adverse events will be monitored to ensure safety.
Detailed Description:
RATIONALE: Following ischemic injury the extracellular matrix (ECM) of the heart adversely remodels leading to cardiac fibrosis, left ventricular (LV) dilatation and subsequent heart failure. Preclinical evidence suggests that the epicardial application of a healthy biologic ECM may reverse the adverse ECM remodeling that takes place following ischemic injury preventing LV dilatation and subsequent heart failure. The investigators have demonstrated that epicardial infarct repair with CorMatrix-ECM restores the damaged ECM, prevents LV dilatation and improves myocardial performance. The investigators believe that epicardial infarct repair may not only restrain the infarcted myocardium to prevent infarct expansion and LV dilatation, but owing to it's biologic nature, help to provide a healthy ECM environment restoring ECM homeostasis and architecture. The investigators therefore propose clinical investigation epicardial infarct repair in patients undergoing coronary artery bypass grafting (CABG) surgery within 6 weeks following acute myocardial infarction as an adjunct to surgical revascularization. This is a patient population commonly referred for CABG surgery. While complete surgical revascularization can prevent further ischemic insult and salvage stunned or hibernating myocardium, it does not restore function to the infarcted myocardium resulting from the acute ischemic injury. The investigator's previous studies suggest that epicardial infarct repair as an adjunct to CABG surgery in this patient population may help improve myocardial function in this previously untreatable territory.
STUDY DESIGN: This is an open-label, non-randomized, feasibility pilot study
PRIMARY OBJECTIVE:
• To evaluate the feasibility of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery in patients undergoing surgery during the subacute period following myocardial infarction (MI).
SECONDARY OBJECTIVES:
* To evaluate the feasibility of identifying the infarct area to be treated by epicardial infarct repair and measure regional function and tissue characteristics within the treated area using cardiac magnetic resonance (CMR) imaging.
* To evaluate the safety of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery.
NUMBER OF SUBJECTS: Eight
TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: CorMatrix-ECM will be surgically applied to the epicardial surface of the anterior LV wall at the time of coronary artery bypass surgery.
CONTROL PRODUCT, DOSE AND ROUTE OF ADMINISTRATION: No control group will be performed in this pilot trial.
DURATION OF SUBJECT PARTICIPATION AND DURATION OF STUDY: Subjects will be involved in the study for up to 6 months.
Screening/Enrollment: 0-6 weeks between acute coronary syndrome presentation and CABG surgery.
Treatment: Day of CABG surgery. Follow-up: 6 months postoperatively. Total duration of the study is expected to be 9 months. Three months for subject enrollment and 6 months for final subject follow-up.
CONCOMMITANT MEDICATIONS:
Prohibited: Immunosuppressive medications (including steroids). Allowed: Any other medications.
FEASIBILITY EVALUATIONS: Feasibility will be accessed through qualitative evaluation by the performing surgeon and successful measurement of cardiac function and tissue characterization by CMR.
PRIMARY ENDPOINT:
• Feasibility of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery in patients undergoing surgery during the subacute period following myocardial infarction (MI) evaluated by the performing surgeon though qualitative observation.
SECONDARY ENDPOINTS:
* Feasibility of measuring regional myocardial function and tissue characteristics within the treated area using cardiac magnetic resonance (CMR) imaging.
* The safety of epicardial infarct repair performed with CorMatrix-ECM.
SAFETY EVALUATIONS :
Adverse events including: all cause mortality; cardiovascular mortality; MACCE; major bleeding events; primary surgical site infection; and myocardial constriction will be recorded.
RATIONALE FOR NUMBER OF STUDY SUBJECTS: This is a pilot study designed to access the feasibility of performing epicardial infarct repair with CorMatrix-ECM in subacute MI patients going for CABG surgery, the feasibility of measuring cardiac function and various tissue characteristics within the treated myocardium by CMR in this patient population, and the safety of epicardial infarct repair performed at the time of CABG surgery. Given the preliminary nature of this study 8 subjects will be tested to confirm feasibility and inform future randomized control trial study design.
STUDY DESIGN: This is an open-label, non-randomized, feasibility pilot study
PRIMARY OBJECTIVE:
• To evaluate the feasibility of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery in patients undergoing surgery during the subacute period following myocardial infarction (MI).
SECONDARY OBJECTIVES:
* To evaluate the feasibility of identifying the infarct area to be treated by epicardial infarct repair and measure regional function and tissue characteristics within the treated area using cardiac magnetic resonance (CMR) imaging.
* To evaluate the safety of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery.
NUMBER OF SUBJECTS: Eight
TEST PRODUCT, DOSE, AND ROUTE OF ADMINISTRATION: CorMatrix-ECM will be surgically applied to the epicardial surface of the anterior LV wall at the time of coronary artery bypass surgery.
CONTROL PRODUCT, DOSE AND ROUTE OF ADMINISTRATION: No control group will be performed in this pilot trial.
DURATION OF SUBJECT PARTICIPATION AND DURATION OF STUDY: Subjects will be involved in the study for up to 6 months.
Screening/Enrollment: 0-6 weeks between acute coronary syndrome presentation and CABG surgery.
Treatment: Day of CABG surgery. Follow-up: 6 months postoperatively. Total duration of the study is expected to be 9 months. Three months for subject enrollment and 6 months for final subject follow-up.
CONCOMMITANT MEDICATIONS:
Prohibited: Immunosuppressive medications (including steroids). Allowed: Any other medications.
FEASIBILITY EVALUATIONS: Feasibility will be accessed through qualitative evaluation by the performing surgeon and successful measurement of cardiac function and tissue characterization by CMR.
PRIMARY ENDPOINT:
• Feasibility of epicardial infarct repair performed with CorMatrix-ECM as an adjunct to CABG surgery in patients undergoing surgery during the subacute period following myocardial infarction (MI) evaluated by the performing surgeon though qualitative observation.
SECONDARY ENDPOINTS:
* Feasibility of measuring regional myocardial function and tissue characteristics within the treated area using cardiac magnetic resonance (CMR) imaging.
* The safety of epicardial infarct repair performed with CorMatrix-ECM.
SAFETY EVALUATIONS :
Adverse events including: all cause mortality; cardiovascular mortality; MACCE; major bleeding events; primary surgical site infection; and myocardial constriction will be recorded.
RATIONALE FOR NUMBER OF STUDY SUBJECTS: This is a pilot study designed to access the feasibility of performing epicardial infarct repair with CorMatrix-ECM in subacute MI patients going for CABG surgery, the feasibility of measuring cardiac function and various tissue characteristics within the treated myocardium by CMR in this patient population, and the safety of epicardial infarct repair performed at the time of CABG surgery. Given the preliminary nature of this study 8 subjects will be tested to confirm feasibility and inform future randomized control trial study design.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: