Trial Outcomes & Findings for Extracellular Matrix Marker of Arrhythmia Risk (EMMA) (NCT NCT00376532)
NCT ID: NCT00376532
Last Updated: 2014-06-04
Results Overview
Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
Recruitment status
COMPLETED
Target enrollment
63 participants
Primary outcome timeframe
At time of enrollment
Results posted on
2014-06-04
Participant Flow
Subjects with Implanted Cardiac Defibrillators were enrolled from the Heart Institute Outpatient Clinic or from the inpatient Electrophysiology Lab at Thomas Jefferson University Hospital
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
32
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Lack sufficient blood sample
|
6
|
6
|
Baseline Characteristics
Extracellular Matrix Marker of Arrhythmia Risk (EMMA)
Baseline characteristics by cohort
| Measure |
ICD Pacing or Shock Event
n=25 Participants
Subjects who experienced a device treatment, defined as a pacing event or a shock event
|
No ICD Pacing or Shock Event
n=26 Participants
Subjects who did not experience a treatment defined as a pacing event or a shock event
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At time of enrollmentSerum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
Outcome measures
| Measure |
ICD Pacing or Shock Event
n=25 Participants
Subjects who experienced a device treatment, defined as a pacing event or a shock event
|
No ICD Pacing or Shock Event
n=26 Participants
Subjects who did not experience a treatment defined as a pacing event or a shock event
|
|---|---|---|
|
MMP-2
|
173493.4 pg/ml
Standard Deviation 110996.7
|
139012.4 pg/ml
Standard Deviation 68988.4
|
PRIMARY outcome
Timeframe: At time of enrollmentSerum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
Outcome measures
| Measure |
ICD Pacing or Shock Event
n=25 Participants
Subjects who experienced a device treatment, defined as a pacing event or a shock event
|
No ICD Pacing or Shock Event
n=26 Participants
Subjects who did not experience a treatment defined as a pacing event or a shock event
|
|---|---|---|
|
MMP-9
|
1033545.8 pg/ml
Standard Deviation 1351216.4
|
680388.5 pg/ml
Standard Deviation 992423.6
|
Adverse Events
ICD Pacing or Shock Event
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No ICD Pacing or Shock Event
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place