PRESERVATION-1
A Placebo Controlled, Multicenter, Randomized Double Blind Trial to Evaluate the Safety and Effectiveness of IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction
Sponsor study identifier
interventional
303
9 countries
82
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Actual (reported)Study Completion
December 2015
Actual (reported)The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous coronary intervention with stent placement after ST segment elevation MI (STEMI).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2010
Actual (reported)October 22, 2010
Actual (reported)April 2012
Date type not reportedThis date has not been verified as actual or estimated.
August 2015
Actual (reported)December 2015
Actual (reported)Left Ventricular End Diastolic Volume Index
Anatomic measurement of left ventricular end diastolic volume index (LVEDVI) assessed through echocardiogram.
Baseline, 6 Months
Kansas City Cardiomyopathy Questionaire
Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits
Six minute walk test
Baseline (prior to discharge STEMI), 1, 3, 6 and 12 month follow-up visits
IK-5001 Sodium Alginate Calcium Gluconate intracoronary injection
Saline Solution intracoronary injection
4 mL (+/- 0.2 mL) administered through intracoronary slow bolus injection over 15 to 30 seconds at least 2 days after PCI but within 5 days of onset of symptoms.
4 mL (+/- 0.2 mL) slow bolus, intracoronary injection of saline solution will be administered over 15 to 30 seconds at least 2 days after percutaneous coronary intervention (PCI) but within 5 days of onset of symptoms.
Cardiology, P.C.
Birmingham, Alabama, 35211, United States
Harbor - UCLA Medical Center
Torrance, California, 90509, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Miami Hospital
Miami, Florida, 33136, United States
St. Vincent Medical Group Inc.
Indianapolis, Indiana, 46290, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Wei X, Chen S, Xie T, Chen H, Jin X, Yang J, Sahar S, Huang H, Zhu S, Liu N, Yu C, Zhu P, Wang W, Zhang W. An MMP-degradable and conductive hydrogel to stabilize HIF-1alpha for recovering cardiac functions. Theranostics. 2022 Jan 1;12(1):127-142. doi: 10.7150/thno.63481. eCollection 2022.
Rao SV, Zeymer U, Douglas PS, Al-Khalidi H, White JA, Liu J, Levy H, Guetta V, Gibson CM, Tanguay JF, Vermeersch P, Roncalli J, Kasprzak JD, Henry TD, Frey N, Kracoff O, Traverse JH, Chew DP, Lopez-Sendon J, Heyrman R, Krucoff MW. Bioabsorbable Intracoronary Matrix for Prevention of Ventricular Remodeling After Myocardial Infarction. J Am Coll Cardiol. 2016 Aug 16;68(7):715-23. doi: 10.1016/j.jacc.2016.05.053.
Ashika Ahmed, MD
Bellerophon Therapeutics
303 participants (actual enrollment reported by the registry).
First Submitted
October 20, 2010
First Posted
October 22, 2010
Study Start
Nicorandil Study to Reduce Cardiac Death After Percutaneous Coronary Intervention (PCI) in Hemodialysis Patients
New York Heart Association (NYHA) functional classification (Physician reported)
Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits
Cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations
5 Years
Re-hospitalization due to any cardiovascular event
5 Years
NT-pro-brain natriuretic peptide (NT-proBNP) levels
Baseline, discharge, 1, 3, and 6 month follow-up visits.
Short Form 12 (SF-12) Questionnaire
Baseline (prior to the index STEMI), 1, 3, 6 and 12 month follow-up visits
Measurement of alginate in plasma and urine
Baseline, 5, 30 min, 1, 3, 8, 24, 48 hrs, 1, 3 month
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Minneapolis Heart Institute
Minneapolis, Minnesota, 55407, United States
Stony Brook Medicine
Stony Brook, New York, 11794, United States
Montefiore Medical Center Weiler Division
The Bronx, New York, 10461, United States
East Carolina Heart Institute - ECHI
Greenville, North Carolina, 27834, United States
Carl and Edyth Lindner Center for Research and Education @ Christ Hospital
Cincinnati, Ohio, 45219, United States
Ohio Health Research Institute
Columbus, Ohio, 43214, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Princess Alexandra Hospital
Woolloongabba, Brisbane, 4102, Australia
Gold Coast Hospital
Southport, Queensland, 4215, Australia
The Queen Elisabeth Hospital
Woodville South, South Australia, 5011, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
The Northern Hospital
Melbourne, Victoria, 3076, Australia
Flinders Medical Centre
Bedford Park, 5042, Australia
Royal Perth Hospital - Dept. of Cardiology
Perth, 6000, Australia
ZNA Middelheim
Antwerp, 2020, Belgium
Universitair Ziekenhuis Brussel
Brussels, 1090, Belgium
Ziekenhuis Oost-Limburg (ZOL)
Genk, 3600, Belgium
CHU du Sart Tilman
Liège, Belgium
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
Queen Elizabeth II Health Science Centre
Halifax, Nova Scotia, B3H 3A7, Canada
York PCI Research
Newmarket, Ontario, L3Y 2P7, Canada
St. Michael's Hospital
Toronto, Ontario, M5B-1W8, Canada
Montreal Heart Institute
Montreal, QC H1T 1C8, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
Québec, 3840, Canada
Centre Hospitalier Universitaire de Sherbrooke
Québec, J1H 5N4, Canada
Hopital de Brive Service de Cardiologie
Brive-la-Gaillarde, 19312, France
Hopital Henri Mondor
Créteil, 94010, France
Hopital du Bocage Central
Dijon, 21079, France
CHU Grenoble - Hopital Michallon
Grenoble, France
Centre Hospitalier Regional Universitaire de Lille
Lille, 59037, France
Centre Hospitalier Universitaire de Nice Hopital Pasteur
Nice, 06002, France
Hopital Lariboisiere
Paris, 75010, France
Nouvel Hopital Civil
Strasbourg, 67091, France
CHU de Toulouse - Hopital Rangueil
Toulouse, 31059, France
Vivantes Netzwerk fur Gesundheit GmbH, Kinikum Neukolln
Berlin, 12351, Germany
Vivantes Humboldt-Klinikum
Berlin, 13509, Germany
Helios Klinikum Erfurt
Erfurt, 99089, Germany
Elisabeth-Krankenhaus
Essen, 45138, Germany
Universitatsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitatsklinikum Jena, Klinik fur Innere Medizin, Kardiologie
Jena, 07747, Germany
Klinik fur Kardiologie and Angiologie Universitatsklinikum
Kiel, 24105, Germany
University of Leipzig
Leipzig, D-04289, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, D-67063, Germany
Universitatsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Universitatsmedizin Mannheim
Mannheim, D-68167, Germany
Klinikum der Universitat Munchen LMU
München, 81377, Germany
Stadtische Kliniken Neuss - Lukaskrankenhaus
Neuss, 41464, Germany
Klinikum Oldenburg gGmbH
Oldenburg, 26133, Germany
St. Marien-Krankenhaus Siegen gem. GMbH
Siegen, 57072, Germany
Krankenhaus Barmherzige Brüder Abt.Kardiologie und Pneumologie
Trier, 54292, Germany
Helios Klinikum Wuppertal
Wuppertal, 42117, Germany
The Edith Wolfson Medical Center
Holon, Tel Aviv, 58100, Israel
HaEmek Medical Center
Afula, 18101, Israel
Barzilai Medical Center
Ashkelon, 78278, Israel
Rambam Medical Center
Haifa, 31096, Israel
The Lady Davis Carmel Medical Center
Haifa, 34362, Israel
B'nai Zion Medical Center
Haifa, Israel
Hadassah University Medical Center Jerusalem-Cardiology
Jerusalem, 91120, Israel
Kaplan Medical Center
Rehovot, Israel
Sheba Medical Center - Tel Hashomer
Tel Litwinsky, 52621, Israel
UCK, Kliniczne Centrum Kardiologii
Gdansk, 80-952, Poland
Centrum Interwencyjnego Leczenia Chorob Serca i Naczyn z Pododdzialem Kardiologii Interwencyjnej
Krakow, 31-202, Poland
I Klinika Kardiologii i Elektrokardiologii lnterwencyjnej oraz Nadcisnienia Tetniczego CM UJ
Krakow, 31-501, Poland
Oddzial Kardiologiczny Wojewodzki Specjalistyczny Szpital im. Bieganskiego w Lodzi
Lodz, 91-347, Poland
Samodzileny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, 20-954, Poland
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie
Szczecin, 70-111, Poland
Pracownia Kardiologii Inwazyjnej
Warsaw, 02-097, Poland
Cetrainy Szpital Kliniczny MSWIA
Warsaw, 02-507, Poland
Hospital del Mar/Passeig Maritim 25-29
Barcelona, 08003, Spain
Hospital Juan Ramon Jimenez
Huelva, 21005, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Clinico de Santiago de Compostela
Santiago, 15706, Spain
Frey N, Linke A, Suselbeck T, Muller-Ehmsen J, Vermeersch P, Schoors D, Rosenberg M, Bea F, Tuvia S, Leor J. Intracoronary delivery of injectable bioabsorbable scaffold (IK-5001) to treat left ventricular remodeling after ST-elevation myocardial infarction: a first-in-man study. Circ Cardiovasc Interv. 2014 Dec;7(6):806-12. doi: 10.1161/CIRCINTERVENTIONS.114.001478. Epub 2014 Oct 28.
April 2012
This date has not been verified as actual or estimated.
Primary Completion
August 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
February 27, 2023
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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