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
About this trial
This is an interventional prevention trial for Arrhythmia
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000464
First Posted
October 27, 1999
Last Updated
July 26, 2013
Sponsor
University of Washington
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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
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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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