- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01539590
Study to Evaluate the Safety and Activity of BB3 to Treat Heart Attack
November 7, 2014 updated by: Angion Biomedica Corp
A Phase 2 Pilot Study to Evaluate the Safety and Activity of BB3 as an Adjunct to Percutaneous Coronary Intervention (PCI) in Subjects Presenting With Acute ST Segment Elevation Myocardial Infarction (STEMI)
The study will evaluate the effect of BB3 to preserve myocardial (heart) tissue and function following myocardial infarction (heart attack).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Percutaneous coronary intervention (PCI) has become the mainstay for treatment of ST-segment elevation myocardial infarction (STEMI).
Whereas early recanalization undoubtedly salvages myocardial tissue, reperfusion following prolonged ischemia can also exacerbate injury.
Infarct size needs to be limited, and the conditions favoring adaptive ventricular healing and remodeling optimized because in patients with acute myocardial infarction (AMI) who do not die of out-of-hospital arrhythmias, long-term prognosis is dependent on the amount of myocardium that is lost, and the outcome of ventricular remodeling.
Angion Biomedical Corp. has identified BB3, a small molecule mimetic of hepatocyte growth factor/scatter factor (HGF/SF) whose activity is expected to preserve tissue viability and attenuate dysfunction in the setting of organ injury while obviating the logistical difficulties associated with gene or protein therapy.
HGF/SF is a naturally occurring cell survival factor that holds significant therapeutic potential.
BB3 has been shown to possess HGF/SF activities, including protection against heart injury following myocardial infarction.
This study is designed to evaluate clinical efficacy of BB3 in patients presenting with acute ST segment elevation myocardial infarction (A-STEMI) who undergo PCI.
Study Type
Interventional
Enrollment (Actual)
5
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55417-1139
- Minneapolis Heart Institute Foundation
-
-
New York
-
New Haven, New York, United States, 06520
- Yale University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has been provided and signed written informed consent, approved by the Institutional Review Board (IRB), prior to performance of any study related procedure including screening procedure.
- Subject is male or female
- Subject is 21 to 80 years of age
- Estimated body weight < 120 kg and BMI < 40
- Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) (e.g., chest pain, arm pain, etc.,) >30 minutes duration and unresponsive to nitroglycerin; with ST segment elevation of more than 1 mm in at least two contiguous leads of ECG or new or presumed new onset bundle branch block (BBB)
- Fulfills clinical center's criteria for primary PCI
- PCI will be done within 12 hours of onset of STEMI.
- The subject and his/her physician are willing to comply with the requirements of the study and the specified follow-up evaluations.
- If female, either surgically sterile or post-menopausal or using acceptable contraception and agree to use effective birth control regimen during the study period. Men must agree to use condoms during the study period. Women of child bearing potential must have a negative urine or serum pregnancy test.
- In the opinion of the Investigator, the subject is capable of understanding and complying with the protocol.
Exclusion Criteria:
- Pregnant or nursing subjects and those who plan pregnancy in the period up to 6 months following index procedure.
- Cardiogenic shock (Killip class 4) or cardiac arrest
- History of prior myocardial infarction or pre-existing Q waves on ECG
- An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first six months post enrollment;
Any contraindication to undergo MRI imaging. This will include any of the following exclusions:
- Cardiac pacemaker or implantable defibrillator;
- Non-MRI-compatible aneurysm clip;
- Neural stimulator (e.g., TENS-Unit);
- Any implanted or magnetically activated device (e.g., insulin pump);
- Any type of non-MRI-compatible metallic ear implant;
- Metal shavings in the orbits;
- Any metallic foreign body, shrapnel, or bullet in a location which the physician feels would present a risk to the subject;
- Any history indicating contraindication to MRI, including claustrophobia or allergy to gadolinium;
- Inability to follow breathhold instructions or to maintain a breathhold for >15 seconds;
- Irregular cardiac rhythm not expected to resolve after treatment of the acute cardiac condition (e.g., chronic atrial fibrillation)
- Known hypersensitivity or contraindication to gadolinium contrast.
- Subject has active bleeding or a history of bleeding diathesis or coagulopathy (including heparin induced thrombocytopenia), or refusal to receive blood transfusions if necessary;
- Subjects presenting with cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or emergency IABP for hypotension treatment) or cardiopulmonary resuscitation prior to randomization;
- History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke; stroke or transient ischemic attack within the past 6 months, or any permanent residual neurologic defect; known preceding cardiac ventricular arrhythmia
- Impaired renal function (eGFR of ≤30 ml/min/1.73m2, as estimated by the MDRD4v equation) or on dialysis.
- Impaired hepatic function (ALT > 2x upper limit of normal, or a total bilirubin greater than 1.5 x upper limit of normal).
- Currently participating in or has participated in an investigational drug or medical device study within 30 days or 5 half-lives, whichever is longer, prior to enrollment into this study
- Have an active malignancy or history of solid, metastatic, or hematologic malignancy with the exception of basal or squamous cell carcinoma of the skin that has been removed
- History of positive human immunodeficiency virus (HIV) test
- History of rheumatoid arthritis
- History of proliferative retinopathy or laser surgery for retinopathy
- Subjects who require cytochrome P450 1A2 (CYP1A2) inhibitors, ciprofloxacin and/or fluvoxamine (Luvox®)
- Subject has other medical illness or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy of less than 6 months,
- Any significant medical condition which in the Investigator's opinion may interfere with the subject's optimal participation in the study;
- Subject has a known hypersensitivity or allergy to stainless steel, nickel, cobalt chromium, nitinol, titanium or known hypersensitivity or allergy to contrast media (e.g. rash) that cannot effectively be controlled by premedication with steroids and/or diphenhydramine. Subjects with hypersensitivity or allergy to any of the components of the device (structural, drug or polymer components) and subjects with true prior anaphylaxis to contrast media should not be enrolled
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BB3
Daily intravenous administration of 2 mg/kg BB3 for four (4) days
|
Daily intravenous administration of 2 mg/kg BB3 for four (4) days
|
Placebo Comparator: Normal Saline
Daily intravenous administration for four (4) days
|
Daily intravenous administration for four (4) days.
The volume of normal saline will vary by estimated weight.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of Reduction in Infarct Size
Time Frame: 6 month
|
Evaluation of reduction in infarct size by MRI between the BB3 and placebo treatment groups at 6 months based on index of myocardial salvage
|
6 month
|
Evaluation of the Degree of Late Ventricular Remodeling
Time Frame: 6 months
|
Evaluation of the degree of late ventricular remodeling between the BB3 and placebo treatment groups at 6 months, as measured by increase in LV end-diastolic volume index (LVEDVI) from initial MR image (day 5±1) to late MR image (6 months).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Body Weight
Time Frame: 6 months
|
6 months
|
|
Change in CK-MB and Troponin
Time Frame: 6 months
|
6 months
|
|
Change in BNP Levels
Time Frame: 6 months
|
6 months
|
|
Change in Symptoms and Clinical Signs of CHF
Time Frame: 6 months
|
6 months
|
|
Change in LVEDVI, LVESVI and LV Ejection Fraction (EF) After MI Assessed by Cine MR (SSFP Imaging)
Time Frame: 6 months
|
6 months
|
|
LVEDVI, LVESVI and LVEF After MI Assessed by 2D and 3D Echocardiography
Time Frame: 6 months
|
6 months
|
|
Change Between Initial Semi-quantitative Regional Wall Motion Score (17 Segment Model) by Echocardiography
Time Frame: 1 and 6 months
|
1 and 6 months
|
|
Change in Regional Myocardial Radial, Circumferential and Longitudinal Strain
Time Frame: 1 and 6 months
|
1 and 6 months
|
|
Frequency of MACE
Time Frame: 6 months
|
6 months
|
|
Frequency of New Onset CHF Through 6 Months
Time Frame: 6 months
|
6 months
|
|
Number of Hospitalizations for CHF Through 6 Months
Time Frame: 6 months
|
6 months
|
|
Incidence of Complete ST Segment Resolution 60 ± 30 Minutes After Last Angiogram
Time Frame: 6 months
|
6 months
|
|
Frequency of AE, SAEs
Time Frame: 6 months
|
6 months
|
|
Frequency of MACCE
Time Frame: 6 months
|
6 months
|
|
All-cause Mortality
Time Frame: 6 months
|
6 months
|
|
Development of Ventricular Fibrillation or Other Life-threatening Arrhythmia
Time Frame: 6 months
|
6 months
|
|
Change From Baseline eCrCl
Time Frame: 6 months
|
6 months
|
|
Symptoms and Clinical Signs of CHF
Time Frame: 6 months
|
Symptoms and clinical signs of CHF measured by NYHA classification
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Weizhong Cai, Sponsor GmbH
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
February 22, 2012
First Submitted That Met QC Criteria
February 22, 2012
First Posted (Estimate)
February 27, 2012
Study Record Updates
Last Update Posted (Estimate)
November 21, 2014
Last Update Submitted That Met QC Criteria
November 7, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001-10
- 5R44HL091699 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Myocardial Infarction
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Fundacio Privada Mon Clinic BarcelonaMiracor Medical SANot yet recruiting
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
Bispebjerg HospitalOdense University Hospital; Zealand University Hospital; Hvidovre University... and other collaboratorsRecruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Denmark
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
Barts & The London NHS TrustUniversity College, London; Queen Mary University of LondonCompletedAcute Myocardial InfarctionSwitzerland, Denmark, United Kingdom
-
Karolinska InstitutetUppsala University; The Swedish Research CouncilActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionSweden
-
Oslo University HospitalVestre Viken Hospital Trust; University of Oslo; University Hospital of North... and other collaboratorsActive, not recruitingST Elevation Myocardial Infarction | Acute Myocardial Infarction | Non-ST Elevation Myocardial InfarctionNorway
Clinical Trials on BB3
-
Angion Biomedica CorpNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Unknown
-
University of Colorado, DenverChildren's Hospital Colorado; Bright by 3; Daniels Fund; Piton Foundation; Gantz...Terminated
-
Angion Biomedica CorpNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)UnknownDelayed Graft FunctionNetherlands, Spain, United Kingdom
-
Angion Biomedica CorpCTI Clinical Trial and Consulting ServicesActive, not recruitingDelayed Graft FunctionUnited States
-
Angion Biomedica CorpCTI Clinical Trial and Consulting ServicesActive, not recruitingStudy to Assess Efficacy and Safety Relative to Standard of Care in Patients With COVID-19 PneumoniaCOVID-19 | PneumoniaBrazil