IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction

Not Applicable

Completed

Conditions: Acute Myocardial Infarction
Congestive Heart Failure
ST-Elevation Myocardial Infarction

Interventions: Device: IK-5001
Device: Saline Solution

Registration Number: NCT01226563

Lead Sponsor: Bellerophon BCM LLC

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).

Detailed Description: Heart failure is a significant problem, and carries substantial mortality. According to studies, left ventricular (LV) remodeling contributes independently to heart failure progression. Prevention and reversal of LV remodeling are correlated with decreased risk of death and heart failure events. IK-5001 is an implantable device to be used in subjects with recent myocardial infarction (MI). The IK-5001 device has been shown to directly halt the remodeling process that occurs following acute MI. IK-5001 replaces the damaged extracellular matrix (ECM) that has degraded during infarction, supports the damaged myocardial tissue, prevents local dyskinesis, and decreases wall stress. Because of its minimal interaction with the myocardium, its mechanism of action, its lack of specific pharmacologic activity and its elimination behavior, IK-5001 is a medical device in concurrence with the Global Harmonization Task Force's harmonized definition for medical devices.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 303

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IK-5001	IK-5001	IK-5001 Sodium Alginate Calcium Gluconate intracoronary injection
Saline Solution	Saline Solution	Saline Solution intracoronary injection

Primary Outcome Measures

Name	Time	Method
Left Ventricular End Diastolic Volume Index	Baseline, 6 Months	Anatomic measurement of left ventricular end diastolic volume index (LVEDVI) assessed through echocardiogram.

Secondary Outcome Measures

Name	Time	Method
Cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations	5 Years	Time to cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations adjudicated by a Clinical Events Committee
Kansas City Cardiomyopathy Questionaire	Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits	Patient reported outcomes (PROs) using The Kansas City Cardiomyopathy Questionaire (KCCQ) score - a validated disease-specific self-administered 23-item questionnaire that will be used to quantify symptoms, function, and quality of life of subjects.
Six minute walk test	Baseline (prior to discharge STEMI), 1, 3, 6 and 12 month follow-up visits	The six minute walk test (6MWT) is used for measuring the response to medical interventions in subjects with moderate to severe heart disease, functional status of subjects, as well as a predictor of morbidity and mortality
New York Heart Association (NYHA) functional classification (Physician reported)	Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits	New York Heart Association (NYHA) classification assessed by physician will be categorized by Class (Class I - IV)
Re-hospitalization due to any cardiovascular event	5 Years	Time to re-hospitalization due to any cardiovascular event

Trial Locations

Locations (82): HaEmek Medical Center
🇮🇱
Afula, Israel
CHU de Toulouse - Hopital Rangueil
🇫🇷
Toulouse, France
CHU Grenoble - Hopital Michallon
🇫🇷
Grenoble Cedex 09, France
Montreal Heart Institute
🇨🇦
Montreal, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM)
🇨🇦
Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
🇨🇦
Quebec, Canada
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
🇩🇪
Ludwigshafen, Germany
Hopital de Brive Service de Cardiologie
🇫🇷
Brive la Gaillarde, France
Hopital du Bocage Central
🇫🇷
Dijon Cedex, France
Centre Hospitalier Universitaire de Nice Hopital Pasteur
🇫🇷
Nice Cedex 1, France
Hopital Henri Mondor
🇫🇷
Creteil Cedex, France
Nouvel Hopital Civil
🇫🇷
Strasbourg Cedex, France
The Edith Wolfson Medical Center
🇮🇱
Holon, Tel Aviv, Israel
Hospital Universitario La Paz
🇪🇸
Madrid, Spain
Universitatsklinikum Heidelberg
🇩🇪
Heidelberg, Germany
Klinikum der Universitat Munchen LMU
🇩🇪
Munchen, Germany
Centre Hospitalier Regional Universitaire de Lille
🇫🇷
Lille, France
Vivantes Netzwerk fur Gesundheit GmbH, Kinikum Neukolln
🇩🇪
Berlin, Germany
Hopital Lariboisiere
🇫🇷
Paris, France
Universitatsklinikum Jena, Klinik fur Innere Medizin, Kardiologie
🇩🇪
Jena, Germany
University of Leipzig
🇩🇪
Leipzig, Germany
Hospital Juan Ramon Jimenez
🇪🇸
Huelva, Spain
B'nai Zion Medical Center
🇮🇱
Haifa, Israel
Hadassah University Medical Center Jerusalem-Cardiology
🇮🇱
Jerusalem, Israel
Vivantes Humboldt-Klinikum
🇩🇪
Berlin, Germany
Helios Klinikum Erfurt
🇩🇪
Erfurt, Germany
Klinikum Oldenburg gGmbH
🇩🇪
Oldenburg, Germany
Hospital Universitario Ramon y Cajal
🇪🇸
Madrid, Spain
Rambam Medical Center
🇮🇱
Haifa, Israel
Universitatsmedizin Mannheim
🇩🇪
Mannheim, Germany
Hospital Clinico de Santiago de Compostela
🇪🇸
Santiago, Spain
Helios Klinikum Wuppertal
🇩🇪
Wuppertal, Germany
Hospital del Mar/Passeig Maritim 25-29
🇪🇸
Barcelona, Spain
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
Cardiology, P.C.
🇺🇸
Birmingham, Alabama, United States
Harbor - UCLA Medical Center
🇺🇸
Torrance, California, United States
MedStar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
University of Florida
🇺🇸
Gainesville, Florida, United States
University of Miami Hospital
🇺🇸
Miami, Florida, United States
St. Vincent Medical Group Inc.
🇺🇸
Indianapolis, Indiana, United States
Minneapolis Heart Institute
🇺🇸
Minneapolis, Minnesota, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
Montefiore Medical Center Weiler Division
🇺🇸
Bronx, New York, United States
Stony Brook Medicine
🇺🇸
Stony Brook, New York, United States
Carl and Edyth Lindner Center for Research and Education @ Christ Hospital
🇺🇸
Cincinnati, Ohio, United States
Ohio Health Research Institute
🇺🇸
Columbus, Ohio, United States
Penn State Milton S. Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States
Princess Alexandra Hospital
🇦🇺
Woolloongabba, Brisbane, Australia
Gold Coast Hospital
🇦🇺
Southport, Queensland, Australia
The Queen Elisabeth Hospital
🇦🇺
Woodville South, South Australia, Australia
Alfred Hospital
🇦🇺
Melbourne, Victoria, Australia
The Northern Hospital
🇦🇺
Melbourne, Victoria, Australia
Flinders Medical Centre
🇦🇺
Bedford Park, Australia
ZNA Middelheim
🇧🇪
Antwerpen, Belgium
Royal Perth Hospital - Dept. of Cardiology
🇦🇺
Perth, Australia
Universitair Ziekenhuis Brussel
🇧🇪
Brussel, Belgium
Ziekenhuis Oost-Limburg (ZOL)
🇧🇪
Genk, Belgium
CHU du Sart Tilman
🇧🇪
Liege, Belgium
Royal Alexandra Hospital
🇨🇦
Edmonton, Alberta, Canada
Queen Elizabeth II Health Science Centre
🇨🇦
Halifax, Nova Scotia, Canada
York PCI Research
🇨🇦
Newmarket, Ontario, Canada
St. Michael's Hospital
🇨🇦
Toronto, Ontario, Canada
I Klinika Kardiologii i Elektrokardiologii lnterwencyjnej oraz Nadcisnienia Tetniczego CM UJ
🇵🇱
Kraków, Poland
UCK, Kliniczne Centrum Kardiologii
🇵🇱
Gdańsk, Poland
Oddzial Kardiologiczny Wojewodzki Specjalistyczny Szpital im. Bieganskiego w Lodzi
🇵🇱
Lodz, Poland
Samodzileny Publiczny Szpital Kliniczny nr 4 w Lublinie
🇵🇱
Lublin, Poland
Barzilai Medical Center
🇮🇱
Ashkelon, Israel
The Lady Davis Carmel Medical Center
🇮🇱
Haifa, Israel
Cetrainy Szpital Kliniczny MSWIA
🇵🇱
Warszawa, Poland
Kaplan Medical Center
🇮🇱
Rehovot, Israel
Sheba Medical Center - Tel Hashomer
🇮🇱
Tel Hashomer, Israel
Centrum Interwencyjnego Leczenia Chorob Serca i Naczyn z Pododdzialem Kardiologii Interwencyjnej
🇵🇱
Krakow, Poland
Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie
🇵🇱
Szczecin, Poland
Pracownia Kardiologii Inwazyjnej
🇵🇱
Warsaw, Poland
Elisabeth-Krankenhaus
🇩🇪
Essen, Germany
Klinik fur Kardiologie and Angiologie Universitatsklinikum
🇩🇪
Kiel, Germany
Universitatsklinikum Schleswig-Holstein
🇩🇪
Lubeck, Germany
Stadtische Kliniken Neuss - Lukaskrankenhaus
🇩🇪
Neuss, Germany
St. Marien-Krankenhaus Siegen gem. GMbH
🇩🇪
Siegen, Germany
Krankenhaus Barmherzige Brüder Abt.Kardiologie und Pneumologie
🇩🇪
Trier, Germany
East Carolina Heart Institute - ECHI
🇺🇸
Greenville, North Carolina, United States
Rhode Island Hospital
🇺🇸
Providence, Rhode Island, United States