Epidemiology of Symptomatic Arrhythmias

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005237
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: May 2000
  Purpose

To acquire a better understanding of the spontaneous clinical behavior of paroxysmal tachycardia by studying epidemiologic features of symptomatic tachycardia patients.


Condition
Cardiovascular Diseases
Heart Diseases
Atrial Fibrillation
Arrhythmia
Tachycardia
Tachycardia, Supraventricular

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: December 1988
Estimated Study Completion Date: November 1993
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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Publications:
Pritchett ELC: Afternoon Arrhythmia. Med Aspects Human Sex, 23:16, January 1989

ClinicalTrials.gov Identifier: NCT00005237     History of Changes
Other Study ID Numbers: 1118
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Atrial Fibrillation
Cardiovascular Diseases
Heart Diseases
Tachycardia
Tachycardia, Supraventricular
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014