- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00376532
Extracellular Matrix Marker of Arrhythmia Risk (EMMA) (EMMA)
Role of Matrix Metaloproteinase(MMP)9 and MMP 2 in Risk Stratification for Ventricular Tachycardia/Fibrillation in Patients With Implanted Cardioverter Defibrillator (ICD) Devices.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19107
- Jefferson Heart Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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ICD pacing or shock event
Subjects who experienced a device treatment, defined as a pacing event or a shock event
|
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No ICD pacing or shock event
Subjects who did not experience a treatment defined as a pacing event or a shock event
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
MMP-2
기간: At time of enrollment
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Serum MMP-2 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
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At time of enrollment
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MMP-9
기간: At time of enrollment
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Serum MMP-9 levels determined by Aushon Biosystems Searchlight® Protein Array Analysis.
|
At time of enrollment
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: David J. Whellan, MD MHS FACC, Thomas Jefferson University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .