Open-label, Test-retest Study to Assess the Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView™
Status: | Completed |
---|---|
Conditions: | Cardiology, Cardiology, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 5/3/2014 |
Start Date: | August 2013 |
End Date: | June 2014 |
Contact: | Chelsea MacMeekin |
Email: | Chelsea.MacMeekin@Quintiles.com |
Phone: | 919-998-2182 |
A Phase 4, Open-label Test-retest Study to Assess the Reproducibility of Quantitative Measurements of Myocardial Uptake of AdreView™ (Iobenguane I 123 Injection)
The aim of the study is to assess the reproducibility of quantitative measurements of
myocardial uptake of Iobenguane I 123 on planar and SPECT imaging following intravenous
(iv.) administration of AdreView. Efficacy will be assessed based upon the absolute
differences between quantitative analyses of imaging data on 2 scans performed 5 to 14 days
apart.
myocardial uptake of Iobenguane I 123 on planar and SPECT imaging following intravenous
(iv.) administration of AdreView. Efficacy will be assessed based upon the absolute
differences between quantitative analyses of imaging data on 2 scans performed 5 to 14 days
apart.
Inclusion Criteria:
- The subject was originally diagnosed with NYHA Class II-III HF due to ischemic heart
disease at least 3 months or due to non-ischemic cardiomyopathy at least 6 months
before enrolment into the study.
- The subject has Left Ventricular (LV) dysfunction with Left Ventricular Ejection
Fraction (LVEF) less than or equal to 35% measured by an appropriate method (e.g.,
radionuclide or contrast ventriculography, electrocardiogram (ECG)-gated SPECT
myocardial perfusion imaging [MPI], magnetic resonance imaging, CT or
echocardiography) within 6 months of enrolment into the study and documented in the
subject's medical record.
- The subject has a history of compliance with prescribed HF medications and takes
Heart Failure (HF) guidelines-based medication at study entry including at a minimum
a beta-blocker and either an angiotensin converting enzyme inhibitor or angiotensin
receptor antagonist unless documented to be intolerant to any of these classes of
medications.
- The subject has been on a stable medical regimen for a minimum of 3 months, with no
hospitalizations or change in HF medications or HF symptoms.
- Subjects must be clinically stable for at least 7 days before enrolling in the study
(e.g., not experiencing continuing chest pain or hemodynamic instability).
Exclusion Criteria:
- The subject has previously received 123I-mIBG or 131I-mIBG.
- The subject has known or suspected hypersensitivity/allergy to iodine, Iobenguane or
to any of the excipients in AdreView.
- The subject has had a heart transplant at any time prior to enrollment.
- The subject had LVEF greater than 35% as measured by an appropriate method (e.g.,
radionuclide or contrast ventriculography, ECG-gated SPECT MPI, MR, CT, or
echocardiography) within 30 days prior to enrolment into the study.
- The subject has received defibrillation (either external or via an implantable
cardioverter defibrillator [ICD]), anti-tachycardia pacing, or cardioversion to treat
an arrhythmic event in the previous 90 days.
- The subject had a cardiac revascularization, insertion of an ICD, or acute myocardial
infarction within 30 days before study entry.
- The subject has renal insufficiency (creatinine greater than 3 mg/dl).
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