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Pathogenesis of Stress-Induced Cardiomyopathy by I-123 MIBG

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ClinicalTrials.gov Identifier: NCT01432626
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : March 22, 2016
Last Update Posted : March 22, 2016
Sponsor:
Collaborator:
GE Healthcare
Information provided by (Responsible Party):
Prem Soman, University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Stress Induced Cardiomyopathy
Intervention Drug: I-123 radiolabeled metaiodobenzylguanidine cardiac imaging
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stress Induced Cardiomyopathy Patients
Hide Arm/Group Description

Patients with stress induced cardiomyopathy, by 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.

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 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.

Period Title: Overall Study
Started 10
Completed 3 [1]
Not Completed 7
Reason Not Completed
LV function recovered             2
Withdrawal by Subject             2
Only 1 image competed             2
Imaging agent not available             1
[1]
Completed both images
Arm/Group Title Stress Induced Cardiomyopathy Patients
Hide Arm/Group Description

Patients with stress induced cardiomyopathy, by 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.

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 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.

Overall Number of Baseline Participants 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  70.0%
>=65 years
3
  30.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants
Female
10
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants
10
1.Primary Outcome
Title 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)
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Stress Induced Cardiomyopathy Patients
Hide Arm/Group Description:

Patients with stress induced cardiomyopathy, by 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.

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 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.

Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
Abnormal at baseline (acute phase) 3
Abnormal at follow up (recovery phase) 1
Time Frame [Not Specified]
Adverse Event Reporting Description Only patients who had at least one scan (n=5) were exposed to any potential adverse events.
 
Arm/Group Title Stress Induced Cardiomyopathy Patients
Hide Arm/Group Description

Patients with stress induced cardiomyopathy, by 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.

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 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.

All-Cause Mortality
Stress Induced Cardiomyopathy Patients
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Stress Induced Cardiomyopathy Patients
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stress Induced Cardiomyopathy Patients
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Prem Soman
Organization: University of Pittsburgh
Phone: 412 647 3435
EMail: somanp@upmc.edu
Layout table for additonal information
Responsible Party: Prem Soman, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01432626     History of Changes
Other Study ID Numbers: PRO10080198
First Submitted: September 7, 2011
First Posted: September 13, 2011
Results First Submitted: March 21, 2016
Results First Posted: March 22, 2016
Last Update Posted: March 22, 2016