Trial to Determine Imaging Parameters of LMI1195 in Heart Failure Patients at Low and High Risk of Defibrillator Firing (LMI1195-201)
October 12, 2015 updated by: Lantheus Medical Imaging
A Multicenter, Phase II, Open Label Trial to Determine Optimal Imaging Parameters and Assess the Safety of LMI 1195 in Low Risk Patients and Heart Failure Patients With a History of Firing of an Implantable Cardioverter-Defibrillator
The purpose of this clinical study is to determine the optimal imaging parameters and assess the safety of LMI1195 -101 in Heart Failure subjects at Low and High Risk of cardiac events.
Study Overview
Detailed Description
- To determine the optimal imaging protocol for a single dose of LMI1195 during positron emission tomography (PET) for the intended study population.
- To assess the safety and tolerability of LMI1195 in patients at low risk of ventricular arrhythmia ("low risk patients") and heart failure patients with a history of firing of an implantable cardioverter defibrillator (ICD) within 6 months prior to enrollment, a documented ejection fraction (EF) ≤ 35%, and a prior diagnosis of NYHA Class II-III heart failure ("heart failure patients") who are undergoing PET imaging.
Study Type
Interventional
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
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New York
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New York, New York, United States, 10032
- Columbia University Medical College
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or non-pregnant female ≥ 18 years of age
- a body weight that is <450 pounds
- Be able to lie flat for at least 2-hour intervals
- Have a normal left ventricular ejection fraction (i.e., ≥ 55% for cohort one or ≤35% for cohort two) by multiple gate acquisition scan (MUGA), echocardiogram or single photon emission computed tomography (SPECT) within 90 days prior, but no less than 3 days prior to enrollment.
- Have been scheduled to undergo or have undergone a SPECT or an approved PET perfusion imaging study performed within 90 days prior to, but no less than 3 days prior to enrollment. to and within the study timeline must be reviewed and deemed acceptable by the judgment of the investigator) (Additional More Specific Criteria can be accessed by contacting an LMI representative)
Exclusion Criteria:
- Have a history of diabetes, coronary artery disease, myocardial infarction heart arrhythmia (except sinus arrhythmia), heart failure, cardiomyopathy (e.g. restrictive, infiltrative or hypertrophic cardiomyopathy), constrictive pericarditis, myocarditis, complex congenital disease, surgically correctable valvular disease, and/or inoperable, obstructive valvular disease, pacemaker, syncope, transient ischemic attack (TIA) or cerebrovascular accident (CVA), Parkinson's disease, degenerative cerebral disease, or organ transplantation.significant comorbid conditions
- Have undergone major surgery within 4 weeks prior to enrollment or planned within 3 weeks after completion of the study.
- Unexplained syncope within 5 years.
- A life expectancy of < 1 year, from any cause.
- Are currently participating in another clinical trial of an investigational product.
- Have clinically significant laboratory abnormalities (e.g., liver enzymes, creatinine, etc.).
- Have a history of smoking within 1 month of enrollment.
- History of drug or alcohol abuse
- Have a history of major psychiatric disorder, active alcohol/drug abuse, and/or history of non-compliance.
- Receipt of any radiopharmaceutical within a period equal to 10 half-lives of the isotope (e.g., for 99mTc, a period of 60 hours; for 111In, a period of 28 days) prior to enrollment or receipt of any radiopharmaceutical containing iodine within a period of 3 months prior to enrollment.
- Have received any of the following medications within 30 days prior to enrollment, because of confounding effects to the autonomic nervous system: albuterol (Alupent, Ventolin within 24 hours), Dobutamine (Dobutrex), Dopamine (Intropin), Epinephrine (Adrenalin), Isoproterenol, Phenylephrine (Neo-Synephrine), Metaraminol (Aramine), Norepinephrine (Levophed), furazolidone (Furoxone), tricyclic antidepressants (Adapin, Asendin, Aventyl, Elavil, Endep, Norpramin, Pamelor, Sinequan, Surmontil, Tofranil, Vivactil), guanethidine (Ismelin), methyldopa (Aldomet). Over the counter herbs that have been reported to interact with adrenergic amines are excluded: ephedra (ma huang), St. John's wort; alfalfa; hibiscus; ginseng; angelica (dong quai); and yohimbe.
- Are not suitable subjects for completion of any screening or trial procedures including PET, scans & laboratory testing,
- Receipt of any radiopharmaceutical within a period of time that the agent has not decayed below background levels
- Have metal that cannot be removed from the body located in the thorax, Receiving Class I or III antiarrhythmic drug therapy, except for amiodarone.
(Additional More Specific Criteria can be accessed by contacting an LMI representative)
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: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Cohort 1
Low risk Heart Failure patients
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Single bolus intravenous injection of LMI 1195
Other Names:
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Experimental: Cohort 2
High risk Heart Failure patients with history of Implantable Cardioverter-Defibrillator firing
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Single bolus intravenous injection of LMI 1195
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Dose acquisition time product, target and non-target F18 count density
Time Frame: Approximately one year
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Approximately one year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Assess Image Quality Data Variability across age & sex stratification Determine Retention Index Values Determine Heart to Mediastinal Ratio Evaluate additional image derived markers that may have predictive value
Time Frame: Approximately one year
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Approximately one year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Veronica Lee, M.D., Lantheus Medical Imaging
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
May 1, 2010
Primary Completion (Anticipated)
February 1, 2011
Study Completion (Anticipated)
February 1, 2011
Study Registration Dates
First Submitted
February 12, 2010
First Submitted That Met QC Criteria
March 10, 2010
First Posted (Estimate)
March 11, 2010
Study Record Updates
Last Update Posted (Estimate)
October 14, 2015
Last Update Submitted That Met QC Criteria
October 12, 2015
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LMI 1195-201
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.