MyocardiopathiesEMMANCT00376532
Extracellular Matrix Marker of Arrhythmia Risk (EMMA)
An observational study of Myocardiopathies and Ischemia, Myocardial, run by Thomas Jefferson University at 1 site in United States.
Trial summary
Assess whether serum levels of MMP 2 and or MMP 9 correlate with episodes of ventricular tachycardia or fibrillation in patients who have implantable cardioverter defibrillator devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardiopathies, Ischemia, Myocardial, Arrythmia
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Sep 2008
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients or outpatients with the cardiac device of interest implanted prior to enrollment.
Who may be able to join
- LVEF of ≤ 35% measured within 6 months of ICD implantation
- NYHA class II-IV at the time of ICD implantation
- ICD implantation at least 1 year prior to enrollment
Who cannot join
- Status post heart transplant
- Known malignancy in the past 2 years.
- Recent procedure, intervention or surgery within the past 90 days
- Acute MI, CABG, or PTCA/stent within the past 2 months.
- Active rheumatoid arthritis or pulmonary or hepatic fibrosis.
- Taking chronic steroid therapy for a medical condition
- Currently pregnant
- Enrolled in a concurrent study that may confound the results of this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Jefferson Heart Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Role of Matrix Metaloproteinase(MMP)9 and MMP 2 in Risk Stratification for Ventricular Tachycardia/Fibrillation in Patients With Implanted Cardioverter Defibrillator (ICD) Devices.
Assess whether serum levels of MMP 2 and or MMP 9 correlate with episodes of ventricular tachycardia or fibrillation in patients who have implantable cardioverter defibrillator devices.
Read the detailed description
Sudden cardiac death (SCD) is responsible for 300,000-450,000 deaths per year in the United States. While it is well known that patients with both ischemic and non-ischemic cardiomyopathy (ICM, NICM) are at increased risk for SCD, there is little beyond ejection fraction which has proven useful as a noninvasive predictor to risk stratify these patients.
Myocardial scar has been validated as an arrhythmic substrate in ischemic populations; the majority of successful ablations for lethal ventricular arrhythmias are performed on tissues in peri-infarct regions. Scar provides an anatomic electrical boundary where peri-infarct zones may lead to areas of slow conduction due to the disruption of inter-myocyte electrical conduction.
Myocardial scar is a less organized collagen deposition which disrupts the typical cardiac extracellular matrix. The collagen matrix provides mechanical support to the myocardium dictating ventricular shape, size and stiffness. While typically relatively dormant, the fibrillar collagen matrix reflects a dynamic relationship between collagen synthesis mediated by fibroblasts and collagen degradation performed by matrix metalloproteinases (MMP).
A marker for scar burden or a marker which could assess a patient's predilection to form scar after either an ischemic or non-ischemic insult may be useful in further risk stratifying this population. Since MMP levels may fluctuate in the course of ischemic or nonischemic injury a static promoter sequence which confers a higher level of MMP expression to an ischemic or nonischemic insult may prove to be a reliable marker. Functional polymorphisms of the MMP-9 gene promoters have been shown in multivariate analysis to be an independent predictor of cardiac mortality regardless of the mechanism of heart failure.
- Keywords
- Cardiac Ischemia, Cardiac Arrhythmia, Defibrillator, Matrix Metalloproteinase, Genetic Polymorphism
- Medical subject headings
- Cardiomyopathies, Myocardial Ischemia, Arrhythmias, Cardiac, Death, Sudden, Cardiac, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMP-2
Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
Measured: At time of enrollment
MMP-9
Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
Measured: At time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyocardiopathiesStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- David J. Whellan, MD MHS FACC, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00376532
- Sponsor's protocol ID
- TJU 06U.282
- Acronym
- EMMA
- Status last verified
- May 2014
- First submitted
- 14 Sep 2006
- Last updated
- 4 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Matrix Metaloproteinase(MMP)9 and MMP 2 in Risk Stratification for Ventricular Tachycardia/Fibrillation in Patients With Implanted Cardioverter Defibrillator (ICD) Devices.
- ClinicalTrials.gov ID
- NCT00376532
- Acronym / sponsor ID
- EMMA / TJU 06U.282
- Keywords
- Cardiac Ischemia, Cardiac Arrhythmia, Defibrillator, Matrix Metalloproteinase, Genetic Polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 15 Sep 2006 (estimated)
- Results
- Posted 4 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Assess whether serum levels of MMP 2 and or MMP 9 correlate with episodes of ventricular tachycardia or fibrillation in patients who have implantable cardioverter defibrillator devices.
Detailed description
Sudden cardiac death (SCD) is responsible for 300,000-450,000 deaths per year in the United States. While it is well known that patients with both ischemic and non-ischemic cardiomyopathy (ICM, NICM) are at increased risk for SCD, there is little beyond ejection fraction which has proven useful as a noninvasive predictor to risk stratify these patients.
Myocardial scar has been validated as an arrhythmic substrate in ischemic populations; the majority of successful ablations for lethal ventricular arrhythmias are performed on tissues in peri-infarct regions. Scar provides an anatomic electrical boundary where peri-infarct zones may lead to areas of slow conduction due to the disruption of inter-myocyte electrical conduction.
Myocardial scar is a less organized collagen deposition which disrupts the typical cardiac extracellular matrix. The collagen matrix provides mechanical support to the myocardium dictating ventricular shape, size and stiffness. While typically relatively dormant, the fibrillar collagen matrix reflects a dynamic relationship between collagen synthesis mediated by fibroblasts and collagen degradation performed by matrix metalloproteinases (MMP).
A marker for scar burden or a marker which could assess a patient's predilection to form scar after either an ischemic or non-ischemic insult may be useful in further risk stratifying this population. Since MMP levels may fluctuate in the course of ischemic or nonischemic injury a static promoter sequence which confers a higher level of MMP expression to an ischemic or nonischemic insult may prove to be a reliable marker. Functional polymorphisms of the MMP-9 gene promoters have been shown in multivariate analysis to be an independent predictor of cardiac mortality regardless of the mechanism of heart failure.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients or outpatients with the cardiac device of interest implanted prior to enrollment.
Key inclusion criteria (3 listed)
- LVEF of ≤ 35% measured within 6 months of ICD implantation
- NYHA class II-IV at the time of ICD implantation
- ICD implantation at least 1 year prior to enrollment
Key exclusion criteria (8 listed)
- Status post heart transplant
- Known malignancy in the past 2 years.
- Recent procedure, intervention or surgery within the past 90 days
- Acute MI, CABG, or PTCA/stent within the past 2 months.
- Active rheumatoid arthritis or pulmonary or hepatic fibrosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MMP-2
Time frame: At time of enrollment
Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
MMP-9
Time frame: At time of enrollment
Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David J. Whellan, MD MHS FACC principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardiopathies and Ischemia, Myocardial, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMP-2 (time frame: At time of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2014; AzTrials last refreshed its copy on 7 Nov 2026.