Epicardial Infarct Repair Using CorMatrix®-ECM: Clinical Feasibility Study

NCT02887768 | Completed Early Phase 1

• 1 other identifier: REB14-1715
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Heart Failure

Outcome Measures

Primary Outcomes (1)

• The number of patients in which the study intervention is successfully completed

  Feasibility will be accessed through qualitative evaluation by the performing surgeon. Successful application of CorMatrix-ECM to the infarcted myocardium at the time of coronary artery bypass grafting surgery will be deemed as successful completion of the study intervention.

  6 weeks

Secondary Outcomes (3)

• The number of patients in which the target myocardium can be successfully identified at the time of surgery

  6 weeks

• The number of patients in which regional myocardial function and tissue characteristics are successfully measured by CMR

  6 months

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Epicardial Infarct Repair with CorMatrix-ECM in addition to coronary artery bypass grafting

Device: Epicardial Infarct Repair with CorMatrix-ECM; Procedure: Coronary Artery Bypass Grafting Surgery

Interventions

Epicardial Infarct Repair with CorMatrix-ECM DEVICE

CorMatrix-ECM-biomaterial will be surgically applied to the epicardial surface of the infarct myocardium at the time of coronary artery bypass surgery

Also known as: SIS-ECM (small intestine submucosa extracellular matrix)

Treatment

Coronary Artery Bypass Grafting Surgery PROCEDURE

All participants will undergo standard coronary artery bypass grafting surgery to treat coronary artery disease

Also known as: Aorto-coronary bypass surgery

Treatment

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient has been diagnosed with an acute STEMI or NSTEMI (confirmed by ST changes on serial ECG, elevated troponin, coronary artery stenosis or occlusion identified by angiography, and a wall motion abnormality identified by angiography or echocardiography)
• The patient is scheduled to undergo coronary artery bypass surgery within 6 weeks of the acute event.
• The patient does not possess any contraindication for CMR.
• The patient is greater then 35-years of age, English speaking, and capable of giving informed consent.
• The patient is geographically accessible and willing to return for all follow-up investigations and clinical visits associated with study.

You may not qualify if:

• The patient is over the age of 75 years.
• The patient has previous MI (other than the qualifying event) and/or has scar or non-viable myocardium identified by CMR in any other LV territory.
• The patient is undergoing other cardiac surgery (i.e. concurrent cardiac valve, or aortic surgery).
• The patient requires emergency surgery (i.e. operative intervention (CABG or ventricular assist device) within 24-hrs of assessment).
• The patient has undergone previous cardiac surgery.
• The patient's postsurgical life expectancy is less than 45 days, in the investigator's opinion.
• The patient is of excessively poor baseline health, health-related quality of life, or physical functioning that would preclude a reasonable expected post-operative recovery.
• The patient has received radiotherapy to the chest wall, is receiving immunosuppressive therapy, or is in any way immunocompromised.
• The patient has a history of malignancy within the past year (other than squamous or basal cell carcinoma, which has been treated without evidence of recurrence).
• The patient has a recent history of drug or alcohol abuse.
• The patient has within 30-days of enrollment or is at anytime during this study participating in any other drug or device study.
• The patient has a known allergy to the CorMatrix-ECM material or any component of the material.
• Absence of non-viable myocardium within the LV on CMR.

Sponsors & Collaborators

• University of Calgary: lead
• Corvivo Cardiovascular, Inc.: collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (2)

• Mewhort HE, Turnbull JD, Satriano A, Chow K, Flewitt JA, Andrei AC, Guzzardi DG, Svystonyuk DA, White JA, Fedak PW. Epicardial infarct repair with bioinductive extracellular matrix promotes vasculogenesis and myocardial recovery. J Heart Lung Transplant. 2016 May;35(5):661-70. doi: 10.1016/j.healun.2016.01.012. Epub 2016 Jan 15.

  PMID: 26987597 RESULT

• Mewhort HE, Turnbull JD, Meijndert HC, Ngu JM, Fedak PW. Epicardial infarct repair with basic fibroblast growth factor-enhanced CorMatrix-ECM biomaterial attenuates postischemic cardiac remodeling. J Thorac Cardiovasc Surg. 2014 May;147(5):1650-9. doi: 10.1016/j.jtcvs.2013.08.005. Epub 2013 Sep 26.

  PMID: 24075463 RESULT

Related Links

• Article: Epicardial infarct repair with bioinductive extracellular matrix promotes vasculogenesis and myocardial recovery

MeSH Terms

Conditions

Acute Coronary Syndrome; Heart Failure

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Paul WM Fedak, MD, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Cardiac Surgeon

Study Record Dates

• First Submitted: April 2, 2016
• First Posted: September 2, 2016
• Study Start: January 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 30, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)