NCT00733590 Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention
| NCT ID | NCT00733590 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | Heart Failure, Congestive |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,500 participants |
| Start Date | 2003-06 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,500 participants in total. It began in 2003-06 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The overall hypothesis of this study is that subtle interactions between structural (substrate) and functional (trigger) abnormalities of the heart, some of which are genetically-determined, can be used to identify patients at high risk of sudden cardiac death (SCD). Such information may be used to better define patients most likely to benefit from replacement of an internal defibrillator (ICD). The prospective, observational study to enroll, categorize and follow patients who receive an ICD pulse generator replacement for primary prevention of SCD (PROSe-ICD) was established to : 1. to gain a better understanding of the biological mechanisms that predispose to SCD 2. to develop readily determined clinical, electrocardiographic, genetic and blood protein markers identify patients with an increased risk of dying suddenly
Eligibility Criteria
Inclusion Criteria: * History of acute MI at least 4 weeks old * Non-ischemic LV dysfunction for at least 9 months * Who have an ejection fraction (EF) \< or = to 35% * Undergone elective replacement indicator (ERI) generator replacement of an FDA-approved ICD for primary prevention of SCD within 24 months of enrollment. * Who have primary prevention implants. Exclusion Criteria: * ICD generator replacement for secondary prevention * Inability or unwillingness to provide valid informed consent * New York Heart Association Class IV heart failure * Patients with pre-existing Class 1 indications for pacemaker therapy.
Contact & Investigator
Katherine C Wu, MD
PRINCIPAL INVESTIGATOR
Associate Professor of Medicine Johns Hopkins University
Frequently Asked Questions
Who can join the NCT00733590 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Heart Failure, Congestive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00733590 currently recruiting?
Yes, NCT00733590 is actively recruiting participants. Contact the research team at kwu@jhmi.edu for enrollment information.
Where is the NCT00733590 trial being conducted?
This trial is being conducted at Washington D.C., United States, Baltimore, United States, Baltimore, United States, Richmond, United States.
Who is sponsoring the NCT00733590 clinical trial?
NCT00733590 is sponsored by Johns Hopkins University. The principal investigator is Katherine C Wu, MD at Associate Professor of Medicine Johns Hopkins University. The trial plans to enroll 1,500 participants.
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