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Acute Myocardial InfarctionPRESERVATION-1NCT01226563

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

A study testing IK-5001 and Saline Solution in people with Acute Myocardial Infarction and Congestive Heart Failure, run by Bellerophon BCM LLC at 82 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IK-5001 and Saline Solution
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
303 participants
Where
82 sitesin 9 countries
Study dates
Apr 2012to Dec 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects must meet all of the following inclusion criteria to participate in this trial:
  • 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
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  • 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.
  • For Germany only: Patients determined to have Killip class 4 at time of device deployment are not eligible for randomization.
  • For Germany only: If SPECT is used for determination of MI size in order to meet inclusion criteria, the SPECT must have been previously performed as part of standard clinical care. SPECT is not to be performed solely to qualify a patient for this study in Germany.

Who cannot join

  • Subjects will be excluded from participating in this trial if ANY of the following exclusion criteria are met:
  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

82 sites in 9 countries.

82 sites in 9 countries

Germany17 sites

  • Vivantes Netzwerk fur Gesundheit GmbH, Kinikum Neukolln

    Berlin, 12351

  • Vivantes Humboldt-Klinikum

    Berlin, 13509

  • Helios Klinikum Erfurt

    Erfurt, 99089

  • Elisabeth-Krankenhaus

    Essen, 45138

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120

  • Universitatsklinikum Jena, Klinik fur Innere Medizin, Kardiologie

    Jena, 07747

  • Klinik fur Kardiologie and Angiologie Universitatsklinikum

    Kiel, 24105

  • University of Leipzig

    Leipzig, D-04289

  • Universitatsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Klinikum der Stadt Ludwigshafen am Rhein gGmbH

    Ludwigshafen, D-67063

  • Universitatsmedizin Mannheim

    Mannheim, D-68167

  • Klinikum der Universitat Munchen LMU

    München, 81377

  • Stadtische Kliniken Neuss - Lukaskrankenhaus

    Neuss, 41464

  • Klinikum Oldenburg gGmbH

    Oldenburg, 26133

  • St. Marien-Krankenhaus Siegen gem. GMbH

    Siegen, 57072

  • Krankenhaus Barmherzige Brüder Abt.Kardiologie und Pneumologie

    Trier, 54292

  • Helios Klinikum Wuppertal

    Wuppertal, 42117

Other trials in Germany

United States16 sites

  • Cardiology, P.C.

    Birmingham, Alabama, 35211

  • Carl and Edyth Lindner Center for Research and Education @ Christ Hospital

    Cincinnati, Ohio, 45219

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • University of Florida

    Gainesville, Florida, 32610

  • East Carolina Heart Institute - ECHI

    Greenville, North Carolina, 27834

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • St. Vincent Medical Group Inc.

    Indianapolis, Indiana, 46290

  • University of Miami Hospital

    Miami, Florida, 33136

  • Minneapolis Heart Institute

    Minneapolis, Minnesota, 55407

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Stony Brook Medicine

    Stony Brook, New York, 11794

  • Montefiore Medical Center Weiler Division

    The Bronx, New York, 10461

  • Harbor - UCLA Medical Center

    Torrance, California, 90509

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

France9 sites

  • Hopital de Brive Service de Cardiologie

    Brive-la-Gaillarde, 19312

  • Hopital Henri Mondor

    Créteil, 94010

  • Hopital du Bocage Central

    Dijon, 21079

  • CHU Grenoble - Hopital Michallon

    Grenoble

  • Centre Hospitalier Regional Universitaire de Lille

    Lille, 59037

  • Centre Hospitalier Universitaire de Nice Hopital Pasteur

    Nice, 06002

  • Hopital Lariboisiere

    Paris, 75010

  • Nouvel Hopital Civil

    Strasbourg, 67091

  • CHU de Toulouse - Hopital Rangueil

    Toulouse, 31059

Other trials in France

Israel9 sites

  • HaEmek Medical Center

    Afula, 18101

  • Barzilai Medical Center

    Ashkelon, 78278

  • Rambam Medical Center

    Haifa, 31096

  • The Lady Davis Carmel Medical Center

    Haifa, 34362

  • B'nai Zion Medical Center

    Haifa

  • The Edith Wolfson Medical Center

    Holon, Tel Aviv, 58100

  • Hadassah University Medical Center Jerusalem-Cardiology

    Jerusalem, 91120

  • Kaplan Medical Center

    Rehovot

  • Sheba Medical Center - Tel Hashomer

    Tel HaShomer, 52621

Other trials in Israel

Poland8 sites

  • UCK, Kliniczne Centrum Kardiologii

    Gdansk, 80-952

  • Centrum Interwencyjnego Leczenia Chorob Serca i Naczyn z Pododdzialem Kardiologii Interwencyjnej

    Krakow, 31-202

  • I Klinika Kardiologii i Elektrokardiologii lnterwencyjnej oraz Nadcisnienia Tetniczego CM UJ

    Krakow, 31-501

  • Oddzial Kardiologiczny Wojewodzki Specjalistyczny Szpital im. Bieganskiego w Lodzi

    Lodz, 91-347

  • Samodzileny Publiczny Szpital Kliniczny nr 4 w Lublinie

    Lublin, 20-954

  • Samodzielny Publiczny Szpital Kliniczny nr 2 PUM w Szczecinie

    Szczecin, 70-111

  • Pracownia Kardiologii Inwazyjnej

    Warsaw, 02-097

  • Cetrainy Szpital Kliniczny MSWIA

    Warsaw, 02-507

Other trials in Poland

Australia7 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • The Northern Hospital

    Melbourne, Victoria, 3076

  • Royal Perth Hospital - Dept. of Cardiology

    Perth, 6000

  • Gold Coast Hospital

    Southport, Queensland, 4215

  • The Queen Elisabeth Hospital

    Woodville South, South Australia, 5011

  • Princess Alexandra Hospital

    Woolloongabba, Brisbane, 4102

Other trials in Australia

Canada7 sites

  • Royal Alexandra Hospital

    Edmonton, Alberta, T5H 3V9

  • Queen Elizabeth II Health Science Centre

    Halifax, Nova Scotia, B3H 3A7

  • Montreal Heart Institute

    Montreal, QC H1T 1C8

  • York PCI Research

    Newmarket, Ontario, L3Y 2P7

  • Centre Hospitalier de l'Universite de Montreal (CHUM)

    Québec, 3840

  • Centre Hospitalier Universitaire de Sherbrooke

    Québec, J1H 5N4

  • St. Michael's Hospital

    Toronto, Ontario, M5B-1W8

Other trials in Canada

Spain5 sites

  • Hospital del Mar/Passeig Maritim 25-29

    Barcelona, 08003

  • Hospital Juan Ramon Jimenez

    Huelva, 21005

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Clinico de Santiago de Compostela

    Santiago, 15706

Other trials in Spain

Belgium4 sites

  • ZNA Middelheim

    Antwerp, 2020

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Ziekenhuis Oost-Limburg (ZOL)

    Genk, 3600

  • CHU du Sart Tilman

    Liège

Other trials in Belgium

About this study

Official title: 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

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).

Read the 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.

Being tested
IK-5001, Saline Solution
Keywords
STEMI, Acute Myocardial Infarction, Congestive Heart Failure, Left Ventricular Remodeling, Devices, Medical
Medical subject headings
Heart Failure, ST Elevation Myocardial Infarction, Ventricular Remodeling

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IK-5001Device

    Also called Sodium Alginate Calcium Gluconate, BIOABSORBABLE CARDIAC MATRIX (BCM)

    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.

  • Saline SolutionDevice

    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.

Study groups in NCT01226563
Study groupRoleWhat they receive
IK-5001ExperimentalIK-5001 Sodium Alginate Calcium Gluconate intracoronary injection
Receives: Device: IK-5001
Saline SolutionPlacebo comparatorSaline Solution intracoronary injection
Receives: Device: Saline Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Left Ventricular End Diastolic Volume Index

    Anatomic measurement of left ventricular end diastolic volume index (LVEDVI) assessed through echocardiogram.

    Measured: Baseline, 6 Months

Secondary outcomes (5)

  1. Kansas City Cardiomyopathy Questionaire

    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.

    Measured: Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits

  2. Six minute walk test

    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

    Measured: Baseline (prior to discharge STEMI), 1, 3, 6 and 12 month follow-up visits

  3. New York Heart Association (NYHA) functional classification (Physician reported)

    New York Heart Association (NYHA) classification assessed by physician will be categorized by Class (Class I - IV)

    Measured: Baseline (prior to index STEMI), 1, 3, 6 and 12 month follow-up visits

  4. Cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations

    Time to cardiovascular death, non-fatal heart failure events or cardiovascular hospitalizations adjudicated by a Clinical Events Committee

    Measured: 5 Years

  5. Re-hospitalization due to any cardiovascular event

    Time to re-hospitalization due to any cardiovascular event

    Measured: 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2010 (estimated)
  2. Study startApr 2012
  3. Primary completionAug 2015
  4. Study completionDec 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effects of IK-5001. 306 trials randomized 2:1 active vs placebo
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01226563
Sponsor's protocol ID
IK-5001-VENREM-201
Acronym
PRESERVATION-1
Status last verified
Jul 2018
First submitted
20 Oct 2010
Last updated
27 Feb 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 34987638

  • 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.

    PubMed 27515331

  • 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.

    PubMed 25351198

Questions about this trial

What is this clinical trial studying?

A study testing IK-5001 and Saline Solution in people with Acute Myocardial Infarction and Congestive Heart Failure, run by Bellerophon BCM LLC at 82 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in Germany, United States, France, Israel, Poland and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Left Ventricular End Diastolic Volume Index (time frame: Baseline, 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01226563, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.

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