Pathogenesis of Stress-Induced Cardiomyopathy by I-123 MIBG

NACompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

December 31, 2014

Study Completion Date

June 30, 2015

Conditions
Stress Induced Cardiomyopathy
Interventions
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.

Trial Locations (1)

15213

University of Pittsburgh Medical Center, Pittsburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GE Healthcare

INDUSTRY

lead

University of Pittsburgh

OTHER

NCT01432626 - Pathogenesis of Stress-Induced Cardiomyopathy by I-123 MIBG | Biotech Hunter | Biotech Hunter