Pathogenesis of Stress-Induced Cardiomyopathy by I-123 MIBG
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.
|Stress Induced Cardiomyopathy||Drug: I-123 radiolabeled metaiodobenzylguanidine cardiac imaging|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||The Evaluation of the Pathogenesis of Stress-Induced Cardiomyopathy by I-123 MIBG Imaging|
- Number of Participants Who Had an Abnormal Regional Uptake of I-123 mIBG at Baseline (Acute Phase) and the Number of Participants Who Had an Abnormal I-123 mIBG Uptake on Follow up (Recovery Phase) [ Time Frame: During the acute phase (2-5 days with an expected mean 3 days) and after recovery of cardiac function (6 weeks) ]Number of participants who had an abnormal regional uptake of I-123 mIBG at baseline (acute phase) and the number of participants who had an abnormal I-123 mIBG uptake on follow up (recovery phase)
|Study Start Date:||September 2011|
|Study Completion Date:||June 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Stress Induced Cardiomyopathy Patients
Patients presenting with stress induced cardiomyopathy, after meeting the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.
Drug: I-123 radiolabeled metaiodobenzylguanidine cardiac imaging
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.
Other Name: AdreVeiw
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01432626
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Prem Soman, MD||University of Pittsburgh Heart Vascular Institute|