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A Study of Stress Echocardiography in Post-Menopausal Women at Risk for Coronary Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00162370
First received: September 9, 2005
Last updated: October 14, 2016
Last verified: September 2014
Results First Received: April 17, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Coronary Artery Disease
Heart Disease
Intervention: Drug: Perflutren Lipid Microsphere Injectable Suspension

  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
Definity

Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.

Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection


Participant Flow for 2 periods

Period 1:   Completed Echocardiography Imaging
    Definity
STARTED   366 [1] 
COMPLETED   366 [2] 
NOT COMPLETED   0 
[1] Received at least one dose of Definity
[2] number of subjects who under went Definity-enhanced rest and stress echocardiogram

Period 2:   Efficacy Population
    Definity
STARTED   366 
COMPLETED   315 [1] 
NOT COMPLETED   51 
Lost to Follow-up                51 
[1] Efficacy population, completed rest/stress echo with Definity & completed 2 and/or 5 year follow up



  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.
Peri- or post-menopausal female subjects between 40 and 65 years of age with an intermediate likelihood of CAD who are scheduled to undergo stress echocardiography

Reporting Groups
  Description
Definity

Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.

Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection


Baseline Measures
   Definity 
Overall Participants Analyzed 
[Units: Participants]
 400 
Age 
[Units: Years]
Mean (Full Range)
 54.4 
 (40 to 65) 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   394 
>=65 years   6 
Gender 
[Units: Participants]
 
Female   400 
Male   0 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   4 
Asian   5 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   4 
White   386 
More than one race   1 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   400 


  Outcome Measures
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1.  Primary:   Percentage of Low to Intermediate Risk Patients Experiencing Future Major Adverse Cardiac Events (MACE)   [ Time Frame: 2 or 5 year follow up ]

2.  Secondary:   Percent of Subjects With Abnormal Stress ECG Testing for Identifying Patients With Major Adverse Cardiac Events (MACE)   [ Time Frame: 2 or 5 year follow up ]

3.  Secondary:   Determine the Value of Exercise Induced Changes in Levels of Cardiac Peptides; Brain Natriuretic Peptide (BNP) in Identifying Patients With Cardiac Events During Follow-up.   [ Time Frame: 2 year or 5 year follow up ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Determine the Value of Brachial Artery Reactivity for Identifying Patients With Cardiac Events During Follow-up.   [ Time Frame: End of Study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Determine the Relative Values of Exercise Echocardiography, Exercise ECG Testing, Cardiac Peptides and Brachial Artery Reactivity for Identifying Patients at Risk of Cardiac Events.   [ Time Frame: End of Study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Determine the Cost-effectiveness of Using Stress Echocardiography in Screening Peri- and Post-menopausal Women at Intermediate Risk for Coronary Artery Disease.   [ Time Frame: End of Study ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sr. Director, Clinical Operations
Organization: Lantheus Medical Imaging
phone: 978-671-8705
e-mail: stiedek@lantheus.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162370     History of Changes
Other Study ID Numbers: DMP 115-407
Study First Received: September 9, 2005
Results First Received: April 17, 2016
Last Updated: October 14, 2016