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Extracellular Matrix Marker of Arrhythmia Risk (EMMA) (EMMA)

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ClinicalTrials.gov Identifier: NCT00376532
Recruitment Status : Completed
First Posted : September 15, 2006
Results First Posted : June 4, 2014
Last Update Posted : June 4, 2014
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Conditions: Myocardiopathies
Ischemia, Myocardial
Arrythmia
Death, Sudden, Cardiac

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects with Implanted Cardiac Defibrillators were enrolled from the Heart Institute Outpatient Clinic or from the inpatient Electrophysiology Lab at Thomas Jefferson University Hospital

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
ICD Event Subjects who experienced a device treatment, defined as a pacing event or a shock event
No ICD Event Subjects who did not experience a treatment defined as a pacing event or a shock event

Participant Flow:   Overall Study
    ICD Event   No ICD Event
STARTED   31 [1]   32 [2] 
COMPLETED   25 [3]   26 [4] 
NOT COMPLETED   6   6 
Lack sufficient blood sample                6                6 
[1] Subjects with an event were enrolled beginning 09/14/2006.
[2] Subjects without an event were enrolled beginning 09/15/2006.
[3] Last event subject enrolled 2/22/2008
[4] Last non-event subject enrolled 3/18/2008.



  Baseline Characteristics

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.
Baseline analysis population was determined by the enrolled subjects for whom the MMP2 and MMP9 assays were completed.

Reporting Groups
  Description
ICD Pacing or Shock Event Subjects who experienced a device treatment, defined as a pacing event or a shock event
No ICD Pacing or Shock Event Subjects who did not experience a treatment defined as a pacing event or a shock event
Total Total of all reporting groups

Baseline Measures
   ICD Pacing or Shock Event   No ICD Pacing or Shock Event   Total 
Overall Participants Analyzed 
[Units: Participants]
 25   26   51 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   13   8   21 
>=65 years   12   18   30 
Gender 
[Units: Participants]
     
Female   3   6   9 
Male   22   20   42 


  Outcome Measures

1.  Primary:   MMP-2   [ Time Frame: At time of enrollment ]

2.  Primary:   MMP-9   [ Time Frame: At time of enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David J. Whellan MD
Organization: Thomas Jefferson University
phone: 215 955 2636
e-mail: david.whellan@jefferson.edu



Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00376532     History of Changes
Other Study ID Numbers: TJU 06U.282
First Submitted: September 14, 2006
First Posted: September 15, 2006
Results First Submitted: May 5, 2014
Results First Posted: June 4, 2014
Last Update Posted: June 4, 2014