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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
Enrollment 63

Recruitment Details 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  
Arm/Group Title ICD Event No ICD Event
Hide Arm/Group Description Subjects who experienced a device treatment, defined as a pacing event or a shock event Subjects who did not experience a treatment defined as a pacing event or a shock event
Period Title: Overall Study
Started 31 [1] 32 [2]
Completed 25 [3] 26 [4]
Not Completed 6 6
Reason Not Completed
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.
Arm/Group Title ICD Pacing or Shock Event No ICD Pacing or Shock Event Total
Hide Arm/Group Description Subjects who experienced a device treatment, defined as a pacing event or a shock event Subjects who did not experience a treatment defined as a pacing event or a shock event Total of all reporting groups
Overall Number of Baseline Participants 25 26 51
Hide Baseline Analysis Population Description
Baseline analysis population was determined by the enrolled subjects for whom the MMP2 and MMP9 assays were completed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 51 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
13
  52.0%
8
  30.8%
21
  41.2%
>=65 years
12
  48.0%
18
  69.2%
30
  58.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 26 participants 51 participants
Female
3
  12.0%
6
  23.1%
9
  17.6%
Male
22
  88.0%
20
  76.9%
42
  82.4%
1.Primary Outcome
Title MMP-2
Hide Description Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
Time Frame At time of enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ICD Pacing or Shock Event No ICD Pacing or Shock Event
Hide Arm/Group Description:
Subjects who experienced a device treatment, defined as a pacing event or a shock event
Subjects who did not experience a treatment defined as a pacing event or a shock event
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: pg/ml
173493.4  (110996.7) 139012.4  (68988.4)
2.Primary Outcome
Title MMP-9
Hide Description Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
Time Frame At time of enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ICD Pacing or Shock Event No ICD Pacing or Shock Event
Hide Arm/Group Description:
Subjects who experienced a device treatment, defined as a pacing event or a shock event
Subjects who did not experience a treatment defined as a pacing event or a shock event
Overall Number of Participants Analyzed 25 26
Mean (Standard Deviation)
Unit of Measure: pg/ml
1033545.8  (1351216.4) 680388.5  (992423.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ICD Pacing or Shock Event No ICD Pacing or Shock Event
Hide Arm/Group Description Subjects who experienced a device treatment, defined as a pacing event or a shock event Subjects who did not experience a treatment defined as a pacing event or a shock event
All-Cause Mortality
ICD Pacing or Shock Event No ICD Pacing or Shock Event
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ICD Pacing or Shock Event No ICD Pacing or Shock Event
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ICD Pacing or Shock Event No ICD Pacing or Shock Event
Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)   0/26 (0.00%) 
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
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