Results of Tc99m-Maraciclatide Scintigraphy in Subjects With Diabetes Mellitus and Heart Failure With Preserved Left Ventricular Ejection Fraction

This study has been terminated.
(Lack of Subject Recruitment)
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01440517
First received: September 22, 2011
Last updated: January 2, 2014
Last verified: January 2014
Results First Received: August 30, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Diabetes Mellitus
Heart Failure
Intervention: Drug: Tc99m-Maraciclatide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tc99m-Maraciclatide Injection The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).

Participant Flow:   Overall Study
    Tc99m-Maraciclatide Injection  
STARTED     5  
COMPLETED     4  
NOT COMPLETED     1  
Subject withdrawn prior to dosing                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Tc99m-Maraciclatide Injection The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).

Baseline Measures
    Tc99m-Maraciclatide Injection  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     3  
>=65 years     1  
Age  
[units: years]
Mean ± Standard Deviation
  63.5  ± 4.2  
Gender  
[units: participants]
 
Female     1  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     4  



  Outcome Measures
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1.  Primary:   Evidence of Active Myocardial Angiogenesis/Remodeling   [ Time Frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. ]

2.  Secondary:   Uptake of 99mTc-maraciclatide Agent in Diabetic Subjects With Heart Failure With Preserved Left Ventricular Fraction and Subjects With Diabetes Mellitus and Asymptomatic Diastolic Dysfunction   [ Time Frame: Time zero equals the date of contrast imaging and for up to 24 hours for safety monitoring post contrast administration. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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:  
Name/Title: Arnold Jacobson, M.D.
Organization: GE Healthcare
phone: 1-609-514-6325
e-mail: Arnold.Jacobson@ge.com


No publications provided


Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01440517     History of Changes
Other Study ID Numbers: GE-078-101
Study First Received: September 22, 2011
Results First Received: August 30, 2013
Last Updated: January 2, 2014
Health Authority: United States: Food and Drug Administration