Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005237
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
Epidemiology of Symptomatic Arrhythmias
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To acquire a better understanding of the spontaneous clinical behavior of paroxysmal tachycardia by studying epidemiologic features of symptomatic tachycardia patients
Detailed Description:
BACKGROUND
Paroxysmal arrhythmias are a group of disorders in which sudden abnormalities of the cardiac rhythm occur without warning Despite the abundant information available from studies on the mechanisms of tachycardias there was hardly a shred of objective data in 1989 to establish how the occurrence of symptomatic tachycardias was influenced by various mechanisms In fact there were very few objective data describing the occurrence of symptomatic tachycardia among the patients who were afflicted with various paroxysmal tachycardias For example were patients in normal sinus rhythm likely to remain free of their tachycardia for one day one week one month or longer The suddenness and apparent unpredictability of attacks of paroxysmal tachycardias have been substantial obstacles to quantitative description of their occurrence These studies used careful documentation of spontaneous tachycardia to establish the epidemiology of symptomatic arrhythmias
DESIGN NARRATIVE
Baseline electrophysiologic methods including intracardiac recording and programmed electrical stimulation were used to determine the mechanism of paroxysmal supraventricular tachycardia All patients had antiarrhythmic medications stopped In most cases the diagnosis of atrial fibrillation was established by scalar electrocardiographic criteria At the time of entry into follow-up each patient was given a cardiobeeper and instructed to record and transmit any symptomatic arrhythmia when it occured Descriptive information about each patient was entered into a baseline data file which included information on the time interval between attacks age sex mechanism of arrhythmia types of associated heart diseases ECG data during sinus rhythm and date and time of call The purpose of the outpatient follow-up was to obtain objective documentation of spontaneously occurring symptomatic tachycardia for quantitative analyses Holter monitoring was used in patients with paroxysmal tachycardias to establish that asymptomatic tachycardia did not occur so often that it constituted an important unrecognized feature of these clinical conditions
Ten consecutively referred patients with paroxysmal supraventricular tachycardia and ten consecutively referred patients with atrial fibrillation underwent untreated surveillance with telephone cardiobeeper monitoring for symptomatic arrhythmias and had four 24-hour ambulatory ECGs recorded at weekly intervals to detect symptomatic and asymptomatic arrhythmias The Cox proportional hazards model was used to test the hypothesis that the mechanism of tachycardia was the most important predictor of the tachycardia-free period during an untreated observation period
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Paroxysmal arrhythmias are a group of disorders in which sudden abnormalities of the cardiac rhythm occur without warning Despite the abundant information available from studies on the mechanisms of tachycardias there was hardly a shred of objective data in 1989 to establish how the occurrence of symptomatic tachycardias was influenced by various mechanisms In fact there were very few objective data describing the occurrence of symptomatic tachycardia among the patients who were afflicted with various paroxysmal tachycardias For example were patients in normal sinus rhythm likely to remain free of their tachycardia for one day one week one month or longer The suddenness and apparent unpredictability of attacks of paroxysmal tachycardias have been substantial obstacles to quantitative description of their occurrence These studies used careful documentation of spontaneous tachycardia to establish the epidemiology of symptomatic arrhythmias
DESIGN NARRATIVE
Baseline electrophysiologic methods including intracardiac recording and programmed electrical stimulation were used to determine the mechanism of paroxysmal supraventricular tachycardia All patients had antiarrhythmic medications stopped In most cases the diagnosis of atrial fibrillation was established by scalar electrocardiographic criteria At the time of entry into follow-up each patient was given a cardiobeeper and instructed to record and transmit any symptomatic arrhythmia when it occured Descriptive information about each patient was entered into a baseline data file which included information on the time interval between attacks age sex mechanism of arrhythmia types of associated heart diseases ECG data during sinus rhythm and date and time of call The purpose of the outpatient follow-up was to obtain objective documentation of spontaneously occurring symptomatic tachycardia for quantitative analyses Holter monitoring was used in patients with paroxysmal tachycardias to establish that asymptomatic tachycardia did not occur so often that it constituted an important unrecognized feature of these clinical conditions
Ten consecutively referred patients with paroxysmal supraventricular tachycardia and ten consecutively referred patients with atrial fibrillation underwent untreated surveillance with telephone cardiobeeper monitoring for symptomatic arrhythmias and had four 24-hour ambulatory ECGs recorded at weekly intervals to detect symptomatic and asymptomatic arrhythmias The Cox proportional hazards model was used to test the hypothesis that the mechanism of tachycardia was the most important predictor of the tachycardia-free period during an untreated observation period
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL040392 | NIH | None | httpsreporternihgovquickSearchR01HL040392 |