title: A randomized, double-blind, placebo-controlled trial to evaluate the safety and effectiveness of intracoronary application of a novel bioabsorbable cardiac matrix for the prevention of ventricular remodeling after large ST-segment elevation myocardial infarction: Rationale and design of the PRESERVATION I trial.
abstract: Postinfarction left ventricular (LV) remodeling can result in chronic heart failure and functional impairment. Although pharmacological strategies for established heart failure can be beneficial, preventing remodeling remains a challenge. Injectable bioabsorbable alginate or "bioabsorbable cardiac matrix" (BCM), composed of an aqueous mixture of sodium alginate and calcium gluconate, is a sterile colorless liquid that is a polysaccharide polymer produced from brown seaweed. When exposed to excess ionized calcium present in infarcted myocardium, BCM assembles to form a flexible gel, structurally resembling extracellular matrix, which provides temporary structural support to the infarct zone through and beyond the time needed for mature fibrotic tissue to develop. The PRESERVATION I trial is an early phase randomized, double-blind, placebo-controlled trial comparing intracoronary application of 4 mL of BCM with saline control in patients who develop large infarctions after successful reperfusion of large ST-segment elevation myocardial infarction (MI). Subjects will be randomized 2:1 to either BCM or saline control and will have the study device deployed through an intracoronary microcatheter in the infarct-related artery 2 to 5 days after index ST-segment elevation MI treated with successful primary or rescue percutaneous coronary intervention. The primary effectiveness end point is the absolute change in LV diastolic volume index as measured by 3-dimensional echocardiography from baseline to 6 months after BCM deployment. Secondary effectiveness end points include clinical outcomes, patient-reported quality of life, additional echocardiographic measures, and functional status measures. In summary, the PRESERVATION I trial is a randomized double-blind trial evaluating the effectiveness and safety of the novel device BCM in preventing LV remodeling patients who have large MIs despite undergoing successful primary or rescue percutaneous coronary intervention.
authors.affiliation: The Duke Clinical Research Institute, Durham, NC. Electronic address: sunil.rao@duke.edu.
authors.forename: Sunil V
authors.initials: SV
authors.lastname: Rao
authors.affiliation: Herzzentrum Ludwigshafen, Ludwigshafen, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Zeymer
authors.affiliation: The Duke Clinical Research Institute, Durham, NC.
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Douglas
authors.affiliation: The Duke Clinical Research Institute, Durham, NC.
authors.forename: Hussein
authors.initials: H
authors.lastname: Al-Khalidi
authors.affiliation: Bellerophon Therapeutics, Inc, Hampton, NJ.
authors.forename: Jingyu
authors.initials: J
authors.lastname: Liu
authors.affiliation: Beth Israel Deaconess Medical Center, Boston, MA.
authors.forename: C Michael
authors.initials: CM
authors.lastname: Gibson
authors.affiliation: The Duke Clinical Research Institute, Durham, NC.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Harrison
authors.affiliation: The Duke Clinical Research Institute, Durham, NC.
authors.forename: Diane S
authors.initials: DS
authors.lastname: Joseph
authors.affiliation: Bellerophon Therapeutics, Inc, Hampton, NJ.
authors.forename: Reinilde
authors.initials: R
authors.lastname: Heyrman
authors.affiliation: The Duke Clinical Research Institute, Durham, NC.
authors.forename: Mitchell W
authors.initials: MW
authors.lastname: Krucoff
mesh_terms: D020341:Absorbable Implants; D000328:Adult; D004311:Double-Blind Method; D015150:Echocardiography, Doppler; D004562:Electrocardiography; D005260:Female; D005500:Follow-Up Studies; D006352:Heart Ventricles / Q000000981:diagnostic imaging / Q000503:physiopathology*; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000175:diagnosis / Q000503:physiopathology / Q000601:surgery*; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D015607:Stents; D013997:Time Factors; D016896:Treatment Outcome; D016277:Ventricular Function, Left; D020257:Ventricular Remodeling