Status:
COMPLETED
Pathogenesis of Stress-Induced Cardiomyopathy by I-123 MIBG
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
GE Healthcare
Conditions:
Stress Induced Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Objective: The objective of this pilot study is to characterize the cardiac uptake patterns of I-123 mIBG in stress-induced (Takotsubo's) cardiomyopathy. Hypothesis: Perturbations in sympathetic inne...
Detailed Description
Background: Since the initial Japanese description of Takotsubo's cardiomyopathy in 1991 as a transient systolic dysfunction of the apical or mid left ventricular segments in the absence of obstructiv...
Eligibility Criteria
Inclusion
- The subject is ≥18 years of age at study entry.
- The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained.
- The subject is male, or a female who is either surgically sterile (has a documented bilateral oophorectomy and/or hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom the result of a urine pregnancy test performed at screening is negative.
- The subject's left heart catheterization (obtained as part of the clinical evaluation) is without clinically significant coronary atherosclerotic disease.
- The subject's echocardiogram (obtained as part of the clinical evaluation) is consistent with a diagnosis of Takotsubo's Cardiomyopathy.
- The patient's electrocardiogram or cardiac enzymes including troponin or CKMB (obtained as part of the clinical evaluation) is abnormal.
- The patient does not have a diagnosis or suspicion of Pheochromocytoma.
Exclusion
- The subject has previously received I123-MIBG or I131-MIBG.
- The subject has a ventricular pacemaker that routinely functions (\>5% paced beats) or has received defibrillation (either external or via an ICD), anti-tachycardic pacing, or cardioversion to treat a previous arrhythmic event.
- The subject was previously entered into this study or has participated in any other investigational medicinal product or medical device study within 30 days of enrollment.
- The subject has a previous history or suspicion of significant allergic reaction or anaphylaxis to iodine or iodinated compounds.
- The subject had cardiac revascularization (eg, percutaneous transluminal coronary angioplasty, PCI, or CABG) or insertion of an ICD within the last 30 days.
- The subject has a serious non-cardiac medical condition associated with significant elevation of plasma catecholamines including Pheochromocytoma.
- The subject is claustrophobic or has a movement disorder that prevents him/her from lying still in a supine position for up to an hour at a time.
- The subject has renal insufficiency (serum creatinine \> 3.0 mg/dl \[265umol/L\]).
- The subject has participated in a research study using ionizing radiation in the previous 12 months.
- The subject has a history of Type I or Type II Diabetes Mellitus with signs of neurological involvement, signs or symptoms of neurological disease (eg, Parkinson's Disease, Multiple System Atrophy, Parkinsonian syndromes), or other diseases known to affect the sympathetic nervous system.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01432626
Start Date
September 1 2011
End Date
June 1 2015
Last Update
March 22 2016
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213