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Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSE-ICD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Johns Hopkins University.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Maryland
Washington Hospital Center
Virginia Commonwealth University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00733590
First received: August 11, 2008
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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 implantation of an internal defibrillator (ICD). The prospective, observational study to enroll, categorize and follow patients who receive an ICD 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

Condition
Heart Failure, Congestive
Death, Sudden, Cardiac
Arrhythmia
Cardiomyopathies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSE-ICD)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Arrhythmic Sudden Death defined as a shock from the ICD for rapid VT or VF or a ventricular arrhythmia not corrected by the ICD [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • All cause mortality, CV mortality, heart transplant, ICD explantation [ Time Frame: total period of observation in the study ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Whole blood drawn at 6 month intervals


Estimated Enrollment: 1200
Study Start Date: June 2003
Estimated Study Completion Date: December 2011
  Hide Detailed Description

Detailed Description:

PROSE-ICD is a multicenter prospective cohort study of patients who undergo ICD implantation for primary prevention of SCD, designed to compare patients who sustain SCD (as measured by an appropriate ICD firing for rapid VT or VF) to those who do not. The cohort for this observational study consists of patients with cardiomyopathy who have an ICD implanted for primary SCD prevention according to recent trials (MADIT II, SCD-HeFT, DEFINITE) and practice guidelines.

Patients are followed longitudinally for clinical, ECG, genomic and proteomic markers and for index events. The primary outcome variable is an appropriate adjudicated ICD firing for rapid ventricular tachycardia or fibrillation.

The study standardizes initial therapeutic ICD settings, reflecting the current standard of care rather than an intervention, because by definition the study cohort consists of patients without a history of malignant arrhythmia, in whom the ICD functions simply as a defibrillator rather than as a more complex device employing anti-tachycardia pacing or tiered therapy. In order to facilitate the identification of rhythms prompting ICD therapy, programming includes far field ventricular electrogram storage. For patients who have firings (appropriate or not), all subsequent clinical care (including drug and device prescriptions) will be managed independently by the clinical attending electrophysiologist/cardiologist according to the local standard of care, unaffected by the study protocol. For safety reasons, any clinically-significant data (such as symptomatic complaints or documented episodes of ventricular arrhythmia) obtained during the study will be promptly communicated to the clinical attending physician both by telephone and in writing.

After informed consent, patients undergo an initial history and examination conducted by an attending electrophysiologist. Thereafter, patients are generally seen by an ICD nurse every 3 months and are evaluated for the purposes of the study every six months. The physician and/or nurse will record the variables shown in Table D1 on paper forms or directly into LIMS web-based entry form. At each routine clinic visit (Q 3 month intervals) the ICD will be interrogated and any episodes of ventricular tachycardia lasting >10 beats with a cycle length < 400 ms, ventricular fibrillation, or any anti-tachycardia pacing or ICD therapies will be recorded. If a ventricular arrhythmia is detected blood will be drawn and a digital ECG will be performed as described for the 6 month follow up visits. Further evaluation and treatment of the arrhythmia will be managed independently by the clinical attending physician, who will be notified of the arrhythmia by telephone, with written confirmation and documentation. At alternate visits (every 6 months) the patient will be evaluated by an attending electrophysiologist, a 60cc blood sample will be obtained, a 5-minute digital ECG, and any additional laboratory and diagnostic testing will be performed as clinically indicated.

Data on clinical events (admission for MI/ACS, admission for CHF, diagnostic angiography, revascularization, ICD device revision) will be collected by medical record review. Patients will be followed for a minimum of four years or until death, cardiac transplantation or ventricular assist device implantation. A patient who experiences an appropriate ICD firing will have been considered to meet the primary endpoint of the study but will continue to be followed, particularly for the development of adverse events.

A clinical events committee comprised of three experienced electrophysiologists, who are not investigators on this study or in the Hopkins Reynolds Center, adjudicate whether ICD firings are appropriate and whether episodes of VT/VF are related to ischemia, based on reports of device interrogation and other clinical documentation.The events committee will also adjudicate deaths in the study as cardiac or non-cardiac and sudden or non-sudden by review of the medical records, records of interviews of family and friends and ICD interrogation. Death within one hour of symptom onset and/or VT/VF on ICD interrogation that was not corrected by the device is considered SCD. All other deaths will be adjudicated as non-sudden including any terminal or hospice chronic care patient whose ICD is programmed off.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with ischemic or non-ischemic cardiomyopathy undergoing ICD implantation 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 implantation of an FDA-approved ICD for primary prevention of SCD within 4 weeks of enrollment

Exclusion Criteria:

  • ICD implantation for secondary prevention
  • inability or unwillingness to provide valid informed consent
  • women < 50 years old with anatomic child-bearing potential who are unwilling to use contraceptives
  • New York Heart Association class IV heart failure
  • patients with permanent pacemakers or pre-existing Class 1 indications for pacemaker implantation
  • unsuccessful ICD implantation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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   
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Stephen R Shorofsky, MD, PhD    800-492-5538    Sshorofs@medicine.umaryland.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
Washington Hospital Center
Virginia Commonwealth University
Investigators
Principal Investigator: Gordon F Tomaselli, MD Professor of Medicine Johns Hopkins University
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gordon F. Tomaselli, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00733590     History of Changes
Other Study ID Numbers: 02-12-16-06, 1RO1-HL091062-01
Study First Received: August 11, 2008
Last Updated: August 3, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
defibrillator, implanted
genomics
electrocardiography
electrophysiological study
proteomics

Additional relevant MeSH terms:
Cardiomyopathies
Death
Death, Sudden
Death, Sudden, Cardiac
Heart Failure
Cardiovascular Diseases
Heart Arrest
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014