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Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)

Primary Purpose

Arrhythmia, Cardiovascular Diseases, Heart Arrest

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
amiodarone
imipramine
mexiletine
procainamide
propafenone
quinidine
sotalol
Sponsored by
University of Washington
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arrhythmia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Men and women with ventricular fibrillation who had survived an out-of-hospital cardiac arrest not associated with a Q-wave acute myocardial infarction.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    July 26, 2013
    Sponsor
    University of Washington
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000464
    Brief Title
    Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1987 (undefined)
    Primary Completion Date
    December 1992 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Washington
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.
    Detailed Description
    BACKGROUND: Sudden cardiac death can usually be attributed to the occurrence of the cardiac arrhythmia, ventricular fibrillation. Although a significant proportion of patients experiencing sudden cardiac death may be successfully resuscitated without disabling sequelae, this event tends to recur. Recurrent sudden cardiac death is more common among patients demonstrating certain clinical characteristics such as: ventricular fibrillation occurring in a setting of a remote prior transmural infarction; the presence of abnormal left ventricular function; male gender; concurrent complex ventricular arrhythmias identified by electrocardiographic monitoring; extensive coronary artery disease; and the ability to induce ventricular arrhythmias following electrical stimulation. Multiple therapeutic approaches are offered to patients surviving primary ventricular fibrillation. In those with evidence of myocardial ischemia, coronary revascularization procedures may be employed. Pharmacological therapy with anti-arrhythmic agents either alone or in combination with selection guided by the results of continuous electrocardiographic monitoring or electrophysiologic studies is often the initial step. For those patients refractory to medical therapy, ventricular resection or implantation of pacemakers has been employed. Amiodarone, a unique antiarrhythmic agent with complex pharmacokinetics and substantial potential toxicity, has been utilized when other antiarrhythmic agents failed. The agent was released as an oral agent for the treatment of ventricular fibrillation in the United States by the FDA. Several investigations suggested that amiodarone was efficacious in the treatment of ventricular fibrillation when other available agents had failed. DESIGN NARRATIVE: Patients were stratified by presence or absence of coronary artery disease, left ventricular function, and presence or absence of drug failure prior to randomization. All patients underwent an evaluation of left ventricular ejection fraction, usually by radionuclide ventriculography, and baseline drug-free Holter recording or electrophysiologic study, or both. A total of 113 patients were randomized to amiodarone and 115 patients to conventional therapy with other antiarrhythmic agents which included procainamide, quinidine, disopyramide, tocainide, mexiletine, encainide, flecainide, propafenone, moricizine, or combination therapy in that order. Holter exams were given at one, three, six, twelve, twenty-four, and thirty-six months. Patients were followed for one to five years, with an average of three years overall. Primary endpoints for the study included in the term 'cardiac survival' were cardiac mortality, resuscitated cardiac arrest due to documented ventricular fibrillation, and complete syncope followed by a shock from an automated implanted defibrillator. These endpoints included sudden arrhythmic cardiac death, resuscitated out-of-hospital ventricular fibrillation, and nonarrhythmic cardiac death. A patient death due to amiodarone pulmonary toxicity was also considered a primary endpoint.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arrhythmia, Cardiovascular Diseases, Heart Arrest, Heart Diseases, Myocardial Infarction, Ventricular Fibrillation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    amiodarone
    Intervention Type
    Drug
    Intervention Name(s)
    imipramine
    Intervention Type
    Drug
    Intervention Name(s)
    mexiletine
    Intervention Type
    Drug
    Intervention Name(s)
    procainamide
    Intervention Type
    Drug
    Intervention Name(s)
    propafenone
    Intervention Type
    Drug
    Intervention Name(s)
    quinidine
    Intervention Type
    Drug
    Intervention Name(s)
    sotalol

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Men and women with ventricular fibrillation who had survived an out-of-hospital cardiac arrest not associated with a Q-wave acute myocardial infarction.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    H. Greene
    Organizational Affiliation
    University of Washington

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    2000790
    Citation
    Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (the CASCADE study). Am J Cardiol. 1991 Mar 15;67(7):578-84. doi: 10.1016/0002-9149(91)90895-r.
    Results Reference
    background
    PubMed Identifier
    2404396
    Citation
    Greene HL. Sudden arrhythmic cardiac death--mechanisms, resuscitation and classification: the Seattle perspective. Am J Cardiol. 1990 Jan 16;65(4):4B-12B. doi: 10.1016/0002-9149(90)91285-e.
    Results Reference
    background
    PubMed Identifier
    2387939
    Citation
    Poole JE, Mathisen TL, Kudenchuk PJ, McAnulty JH, Swerdlow CD, Bardy GH, Greene HL. Long-term outcome in patients who survive out of hospital ventricular fibrillation and undergo electrophysiologic studies: evaluation by electrophysiologic subgroups. J Am Coll Cardiol. 1990 Sep;16(3):657-65. doi: 10.1016/0735-1097(90)90357-u.
    Results Reference
    background
    PubMed Identifier
    2330894
    Citation
    Dolack GL, Callahan DB, Bardy GH, Greene HL. Signal-averaged electrocardiographic late potentials in resuscitated survivors of out-of-hospital ventricular fibrillation. Am J Cardiol. 1990 May 1;65(16):1102-4. doi: 10.1016/0002-9149(90)90321-q.
    Results Reference
    background
    PubMed Identifier
    2317907
    Citation
    Bardy GH, Allen MD, Mehra R, Johnson G, Feldman S, Greene HL, Ivey TD. Transvenous defibrillation in humans via the coronary sinus. Circulation. 1990 Apr;81(4):1252-9. doi: 10.1161/01.cir.81.4.1252.
    Results Reference
    background
    PubMed Identifier
    1860210
    Citation
    Bardy GH, Troutman C, Johnson G, Mehra R, Poole JE, Dolack GL, Kudenchuk PJ, Gartman DM. Electrode system influence on biphasic waveform defibrillation efficacy in humans. Circulation. 1991 Aug;84(2):665-71. doi: 10.1161/01.cir.84.2.665.
    Results Reference
    background
    PubMed Identifier
    8342505
    Citation
    Randomized antiarrhythmic drug therapy in survivors of cardiac arrest (the CASCADE Study). The CASCADE Investigators. Am J Cardiol. 1993 Aug 1;72(3):280-7. doi: 10.1016/0002-9149(93)90673-z.
    Results Reference
    background
    PubMed Identifier
    8296753
    Citation
    Dolack GL. Clinical predictors of implantable cardioverter-defibrillator shocks (results of the CASCADE trial). Cardiac Arrest in Seattle, Conventional versus Amiodarone Drug Evaluation. Am J Cardiol. 1994 Feb 1;73(4):237-41. doi: 10.1016/0002-9149(94)90226-7.
    Results Reference
    background
    PubMed Identifier
    8237833
    Citation
    Greene HL. The CASCADE Study: randomized antiarrhythmic drug therapy in survivors of cardiac arrest in Seattle. CASCADE Investigators. Am J Cardiol. 1993 Nov 26;72(16):70F-74F. doi: 10.1016/0002-9149(93)90966-g.
    Results Reference
    background
    PubMed Identifier
    8256707
    Citation
    Maynard C. Rehospitalization in surviving patients of out-of-hospital ventricular fibrillation (the CASCADE Study). Cardiac Arrest in Seattle: Conventional Amiodarone Drug Evaluation. Am J Cardiol. 1993 Dec 1;72(17):1295-300. doi: 10.1016/0002-9149(93)90300-2.
    Results Reference
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    Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)

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