Pathogenesis of Stress-Induced Cardiomyopathy by I-123 MIBG

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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 innervation are the underlying pathogenesis of stress induced cardiomyopathy and will result in abnormalities in I-123 mIBG cardiac imaging. Thus, planar and SPECT I-123 MIBG imaging will provide insight into the pathogenesis of stress-induced cardiomyopathy, and may lead to the development of more specific diagnostic criteria.

Study design: This proposal is for a prospective pilot study to characterize perturbations in cardiac sympathetic innervation in patients with stress induced cardiomyopathy by performing planar and SPECT I-123 MIBG imaging during the acute presentation and after recovery of LV function.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: GE Healthcare
• Treatments: 3-Iodobenzylguanidine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.