IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction
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
1 other identifier
interventional
303
9 countries
82
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2012
Longer than P75 for not_applicable
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2010
CompletedFirst Posted
Study publicly available on registry
October 22, 2010
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 27, 2023
July 1, 2018
3.3 years
October 20, 2010
February 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left Ventricular End Diastolic Volume Index
Anatomic measurement of left ventricular end diastolic volume index (LVEDVI) assessed through echocardiogram.
Baseline, 6 Months
Secondary Outcomes (5)
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
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
Other Outcomes (10)
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
- +7 more other outcomes
Study Arms (2)
IK-5001
EXPERIMENTALIK-5001 Sodium Alginate Calcium Gluconate intracoronary injection
Saline Solution
PLACEBO COMPARATORSaline Solution intracoronary injection
Interventions
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.
Eligibility Criteria
You may qualify if:
- The subject is ≥ 18 years of age.
- The subject has given informed consent.
- The subject has experienced a large STEMI defined by the following criteria:
- Peak cardiac enzyme value within 48 hours of symptom onset as follows:
- Creatine kinase MB fraction (CK-MB) \> 30 x the upper limit of normal OR
- Troponin I \> 200 x upper limit of normal OR
- Troponin T \> 60 x the upper limit of normal
- AND at least 1 of the following 3 criteria:
- Delayed presentation with PCI \> 6 hours from onset of symptoms
- Significant new Q waves in ≥ 2 anterior leads or anterior ST segment elevation of at least 3 mm persistent at 24 hours after PCI
- New onset of CHF (Killip class 3-4) or cardiogenic shock persistent at 24 hours after PCI
- AND at least 1 of the following 2 criteria:
- MI ≥ 20% by Single Photon Emission Computed Tomography scan (SPECT) or cardiac Magnetic Resonance Imaging (MRI) with defect in the appropriate distribution
- Ejection fraction ≤ 35% with wall motion abnormality in the appropriate distribution at baseline imaging assessment
- The subject has had successful PCI with stent within 48 hours of symptom onset, and residual stenosis less than 20% in the infarct related artery and greater than or equal to thrombolysis in myocardial infarction (TIMI) 2 flow. Subjects undergoing rescue PCI after thrombolysis or delayed presentation with ongoing ischemia may be enrolled.
- +1 more criteria
You may not qualify if:
- Any subject with cardiogenic shock requiring mechanical ventilation or mechanical support at the time of deployment. Subject must be off mechanical support prior to deployment.
- Need for urgent coronary artery bypass graft (CABG)
- Clinically significant valvular heart disease with planned surgical correction or transcatheter aortic valve implantation (TAVI)
- Uncontrolled ventricular arrhythmias
- Renal insufficiency with a calculated creatinine clearance of less than 30 mL/ minute. See Appendix A for determining estimated creatinine clearance.
- Clinically significant hepatic insufficiency
- Inadequate imaging windows (defined as the inability to visualize the endocardial border of at least 16 of the 17 segments in both the apical four chambers and apical two chamber views without foreshortening) or arrhythmia that would preclude adequate 3D imaging on transthoracic echocardiography at the local baseline echo assessment
- Non-ambulatory prior to the index MI
- The subject has participated in another trial of an investigational agent within 30 days prior to randomization.
- Subject has received resorbable stent as part of PCI.
- The subject is pregnant or breastfeeding. Women of child-bearing potential will have a negative urine pregnancy test prior to randomization.
- Any other concurrent condition that, in the opinion of the investigator, would prevent completion of the clinical trial, including inability to comply with follow up requirements.
- For Germany only: In the investigator's opinion, the patient is not expected to survive ≥12 months.
- For Germany only: 24 hours prior to device deployment, the patient has a serum calcium level greater than the upper limit of normal as determined by the local laboratory.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
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
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
Related Publications (3)
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.
PMID: 34987638DERIVEDRao 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.
PMID: 27515331DERIVEDFrey 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.
PMID: 25351198DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ashika Ahmed, MD
Bellerophon Therapeutics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- randomized 2:1 active vs placebo
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2010
First Posted
October 22, 2010
Study Start
April 1, 2012
Primary Completion
August 1, 2015
Study Completion
December 1, 2015
Last Updated
February 27, 2023
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share