At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at study entry
- ✓Left heart catheterization without clinically significant coronary atherosclerotic disease
- ✓Echocardiogram consistent with Takotsubo cardiomyopathy diagnosis
- ✓Abnormal electrocardiogram or elevated cardiac enzymes (troponin or CKMB)
- ✕Previous receipt of I-123 MIBG or I-131 MIBG
- ✕Ventricular pacemaker that routinely functions (>5% paced beats) or prior defibrillation, anti-tachycardic pacing, or cardioversion for arrhythmia
- ✕Participation in another investigational study within 30 days of enrollment
- ✕History or suspicion of significant allergic reaction or anaphylaxis to iodine or iodinated compounds
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Evaluation of the Pathogenesis of Stress-Induced Cardiomyopathy by I-123 MIBG Imaging
In Brief
A clinical study evaluating I-123 radiolabeled metaiodobenzylguanidine cardiac imaging for Stress Induced Cardiomyopathy. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The investigational medicinal product will be administered in a volume of 5 mL (diluted using 0.9% sodium chloride as needed) and injected over 1 to 2 minutes. The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later. This means that each study subject will receive a total of 2 doses of I123-mIBG at 2 different time points.