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Myocardial InfarctionPhase 2NCT01539590

Study to Evaluate the Safety and Activity of BB3 to Treat Heart Attack

A Phase 2 study testing BB3 and Normal saline in people with Myocardial Infarction, run by Angion Biomedica Corp at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study will evaluate the effect of BB3 to preserve myocardial (heart) tissue and function following myocardial infarction (heart attack). Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Myocardial Infarction
What is being tested?
BB3 and Normal saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5 participants
Where
2 sitesUnited States
Study dates
Jul 2012to Nov 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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;
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  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55417-1139

  • Yale University Medical Center

    New Haven, New York, 06520

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
BB3, Normal saline
Keywords
hepatocyte growth factor mimetic, hepatocyte growth factor(HGF), Myocardial Infarction, Acute ST Segment Elevation Myocardial Infarction (STEMI), Percutaneous Coronary Intervention (PCI)
Medical subject headings
Myocardial Infarction, Deafness, Autosomal Recessive 39, ST Elevation Myocardial Infarction

What participants receive

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

  • BB3Drug

    Daily intravenous administration of 2 mg/kg BB3 for four (4) days

  • Normal salineDrug

    Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.

Study groups in NCT01539590
Study groupRoleWhat they receive
BB3ExperimentalDaily intravenous administration of 2 mg/kg BB3 for four (4) days
Receives: Drug: BB3
Normal SalinePlacebo comparatorDaily intravenous administration for four (4) days
Receives: Drug: Normal saline

What is being measured

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

  1. Evaluation of Reduction in Infarct Size

    Evaluation of reduction in infarct size by MRI between the BB3 and placebo treatment groups at 6 months based on index of myocardial salvage

    Measured: 6 month

  2. Evaluation of the Degree of Late Ventricular Remodeling

    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).

    Measured: 6 months

Secondary outcomes (18)

  1. Change in CK-MB and Troponin

    Measured: 6 months

  2. Change in BNP Levels

    Measured: 6 months

  3. Change in Symptoms and Clinical Signs of CHF

    Measured: 6 months

  4. Change in LVEDVI, LVESVI and LV Ejection Fraction (EF) After MI Assessed by Cine MR (SSFP Imaging)

    Measured: 6 months

  5. LVEDVI, LVESVI and LVEF After MI Assessed by 2D and 3D Echocardiography

    Measured: 6 months

  6. Change Between Initial Semi-quantitative Regional Wall Motion Score (17 Segment Model) by Echocardiography

    Measured: 1 and 6 months

  7. Change in Regional Myocardial Radial, Circumferential and Longitudinal Strain

    Measured: 1 and 6 months

  8. Frequency of MACE

    Measured: 6 months

  9. Frequency of New Onset CHF Through 6 Months

    Measured: 6 months

  10. Number of Hospitalizations for CHF Through 6 Months

    Measured: 6 months

  11. Incidence of Complete ST Segment Resolution 60 ± 30 Minutes After Last Angiogram

    Measured: 6 months

  12. Frequency of AE, SAEs

    Measured: 6 months

  13. Frequency of MACCE

    Measured: 6 months

  14. All-cause Mortality

    Measured: 6 months

  15. Development of Ventricular Fibrillation or Other Life-threatening Arrhythmia

    Measured: 6 months

  16. Change From Baseline eCrCl

    Measured: 6 months

  17. Change in Body Weight

    Measured: 6 months

  18. Symptoms and Clinical Signs of CHF

    Symptoms and clinical signs of CHF measured by NYHA classification

    Measured: 6 months

Timeline

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

  1. First posted27 Feb 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJul 2013
  4. Study completionNov 2013

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01539590
Sponsor's protocol ID
001-10
Other IDs
5R44HL091699
Status last verified
Nov 2014
First submitted
22 Feb 2012
Last updated
21 Nov 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BB3 and Normal saline in people with Myocardial Infarction, run by Angion Biomedica Corp at 2 sites in United States.

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 10 inclusion and 30 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: stopped early, as of the sponsor's last update on 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Evaluation of Reduction in Infarct Size (time frame: 6 month). The study lists 2 primary outcomes in all. 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 NCT01539590.

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 21 Nov 2014.

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