Trial to Determine Imaging Parameters of LMI1195 in Heart Failure Patients at Low and High Risk of Defibrillator Firing

NCT01085175 | Withdrawn Phase 2 DMC

• 1 other identifier: LMI 1195-201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Failure

Keywords

Heart Failure,; PET Imaging,; Implantable Cardioverter-Defibrillator,; Sudden Cardiac Death

Outcome Measures

Primary Outcomes (1)

• Dose acquisition time product, target and non-target F18 count density

  Approximately one year

Secondary Outcomes (1)

• 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

  Approximately one year

Study Arms (2)

Cohort 1

EXPERIMENTAL

Low risk Heart Failure patients

Drug: LMI 1195

Cohort 2

EXPERIMENTAL

High risk Heart Failure patients with history of Implantable Cardioverter-Defibrillator firing

Drug: LMI 1195

Interventions

LMI 1195 DRUG

Single bolus intravenous injection of LMI 1195

Also known as: LMI 1195-101 Clinical Trial

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lantheus Medical Imaging: lead

Study Sites (1)

Columbia University Medical College

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Heart Failure; Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Arrest; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Veronica Lee, M.D.

  Lantheus Medical Imaging

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2010
• First Posted: March 11, 2010
• Study Start: May 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 14, 2015

Record last verified: 2011-02

Locations

US (1)