Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSE-ICD)
Recruitment status was Recruiting
|First Received Date ICMJE||August 11, 2008|
|Last Updated Date||August 3, 2009|
|Start Date ICMJE||June 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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 ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00733590 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||All cause mortality, CV mortality, heart transplant, ICD explantation [ Time Frame: total period of observation in the study ] [ Designated as safety issue: Yes ]|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention|
|Official Title ICMJE||Prospective Observational Study of the ICD in Sudden Cardiac Death Prevention (PROSE-ICD)|
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 :
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Cohort
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Biospecimen||Retention: Samples With DNA
Whole blood drawn at 6 month intervals
|Sampling Method||Non-Probability Sample|
Patients with ischemic or non-ischemic cardiomyopathy undergoing ICD implantation for primary prevention
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1200|
|Estimated Completion Date||December 2011|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 85 Years|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00733590|
|Other Study ID Numbers ICMJE||02-12-16-06, 1RO1-HL091062-01|
|Has Data Monitoring Committee||No|
|Responsible Party||Gordon F. Tomaselli, Johns Hopkins University|
|Study Sponsor ICMJE||Johns Hopkins University|
|Information Provided By||Johns Hopkins University|
|Verification Date||August 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP