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

• Published in: The American heart journal Vol. 170; no. 5; pp. 929 - 937
• Main Authors: Rao, Sunil V., MD, Zeymer, Uwe, MD, Douglas, Pamela S., MD, Al-Khalidi, Hussein, PhD, Liu, Jingyu, PhD, Gibson, C. Michael, MD, Harrison, Robert W., MD, Joseph, Diane S., BS, Heyrman, Reinilde, MD, Krucoff, Mitchell W., MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.11.2015; Elsevier Limited
• Subjects: Absorbable Implants; Adult; Cardiology; Cardiovascular; Double-Blind Method; Echocardiography, Doppler; Electrocardiography; Female; Follow-Up Studies; Heart attacks; Heart failure; Heart Ventricles - diagnostic imaging; Heart Ventricles - physiopathology; Human subjects; Humans; Laboratories; Male; Medical prognosis; Mortality; Myocardial Infarction - diagnosis; Myocardial Infarction - physiopathology; Myocardial Infarction - surgery; Percutaneous Coronary Intervention - methods; Plasma; Preservation; Stents; Time Factors; Treatment Outcome; Ventricular Function, Left; Ventricular Remodeling
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2015.08.017

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.