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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.
- Source :
-
American heart journal [Am Heart J] 2015 Nov; Vol. 170 (5), pp. 929-37. Date of Electronic Publication: 2015 Aug 24. - Publication Year :
- 2015
-
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.<br /> (Copyright © 2015 Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Double-Blind Method
Echocardiography, Doppler
Female
Follow-Up Studies
Heart Ventricles diagnostic imaging
Humans
Male
Myocardial Infarction diagnosis
Myocardial Infarction physiopathology
Time Factors
Treatment Outcome
Ventricular Function, Left
Absorbable Implants
Electrocardiography
Heart Ventricles physiopathology
Myocardial Infarction surgery
Percutaneous Coronary Intervention methods
Stents
Ventricular Remodeling
Subjects
Details
- Language :
- English
- ISSN :
- 1097-6744
- Volume :
- 170
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- American heart journal
- Publication Type :
- Academic Journal
- Accession number :
- 26542501
- Full Text :
- https://doi.org/10.1016/j.ahj.2015.08.017