Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD)
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| ClinicalTrials.gov Identifier: NCT00733590 |
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Recruitment Status :
Recruiting
First Posted : August 13, 2008
Last Update Posted : August 6, 2019
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Sponsor:
Johns Hopkins University
Collaborators:
University of Maryland, College Park
Washington Hospital Center
Virginia Commonwealth University
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University
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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 :
- to gain a better understanding of the biological mechanisms that predispose to SCD
- to develop readily determined clinical, electrocardiographic, genetic and blood protein markers identify patients with an increased risk of dying suddenly
| Condition or disease |
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| Heart Failure, Congestive Death, Sudden, Cardiac Arrhythmia Cardiomyopathies |
Show Detailed Description
| Study Type : | Observational |
| Estimated Enrollment : | 1500 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSe-ICD) |
| Actual Study Start Date : | June 2003 |
| Estimated Primary Completion Date : | March 2021 |
| Estimated Study Completion Date : | March 2022 |
Primary Outcome Measures :
- Arrhythmic Sudden Death defined as a therapy from the ICD for rapid VT or VF or a ventricular arrhythmia not corrected by the ICD [ Time Frame: 10 years ]
Secondary Outcome Measures :
- All cause mortality, CV mortality, heart transplant, LVAD, and ICD explantation or ICD Disabled [ Time Frame: Total period of observation in the study ]
Biospecimen Retention: Samples With DNA
Whole blood drawn at 6-12 month intervals
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with ischemic or non-ischemic cardiomyopathy undergoing their first ICD generator replacement for primary prevention.
Criteria
Inclusion Criteria:
- History of acute MI at least 4 weeks old
- Non-ischemic LV dysfunction for at least 9 months
- Who have an EF < or = to 35%
- Undergone first ERI generator replacement of an FDA-approved ICD for primary prevention of SCD within 12 months of enrollment
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.
- CRT-D devices.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00733590
Contacts
| Contact: Barbara Butcher, BSN | 443 287-3472 | bbutche1@jhmi.edu |
Locations
| United States, District of Columbia | |
| Washington Hospital Center | Recruiting |
| Washington, District of Columbia, United States, 20010 | |
| Contact: Zayd Eldadah, MD, PhD 202-877-7865 Zayd.Eldadah@Medstar.Net | |
| United States, Maryland | |
| University of Maryland Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Stephen R Shorofsky, MD, PhD 800-492-5538 Sshorofs@medicine.umaryland.edu | |
| Johns Hopkins University School of Medicine | Recruiting |
| Baltimore, Maryland, United States, 21205 | |
| Contact: Barbara Butcher, BSN 443-287-3472 bbutche1@jhmi.edu | |
| Contact: Gordon Tomaselli, MD 410 955-2774 gtomasel@jhmi.edu | |
| United States, Virginia | |
| Virginia Commonwealth University School of Medicine | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Kenneth Ellenbogen, MD 804-828-7576 kellenbogen@pol.net | |
Sponsors and Collaborators
Johns Hopkins University
University of Maryland, College Park
Washington Hospital Center
Virginia Commonwealth University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
| Principal Investigator: | Gordon F Tomaselli, MD | Professor of Medicine Johns Hopkins University |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Johns Hopkins University |
| ClinicalTrials.gov Identifier: | NCT00733590 History of Changes |
| Other Study ID Numbers: |
NA_00045142 5R01HL091062 ( U.S. NIH Grant/Contract ) |
| First Posted: | August 13, 2008 Key Record Dates |
| Last Update Posted: | August 6, 2019 |
| Last Verified: | August 2019 |
Keywords provided by Johns Hopkins University:
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defibrillator, implanted genomics electrocardiography electrophysiological study proteomics |
Additional relevant MeSH terms:
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Heart Failure Cardiomyopathies Death, Sudden, Cardiac Death Death, Sudden |
Heart Diseases Cardiovascular Diseases Pathologic Processes Heart Arrest |