Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 27 of 42 for:    Syncope | Child

Identifying High Risk Patients With Syncope

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00005202
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : May 13, 2016
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Tracking Information
First Submitted Date May 25, 2000
First Posted Date May 26, 2000
Last Update Posted Date May 13, 2016
Study Start Date July 1987
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00005202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Identifying High Risk Patients With Syncope
Official Title Not Provided
Brief Summary To validate two models which categorized patients with syncope into high and low risk for either sudden death or diagnostic arrhythmias based on data available from the initial history, physical examination, and electrocardiogram.
Detailed Description

BACKGROUND:

Syncope is a common medical problem with up to 30 percent of normal individuals reporting one or more syncopal episodes. Thus, physicians of all specialties are frequently confronted by patients with syncope. The spectrum of diseases which may cause syncope is broad, ranging from common benign problems to severe life-threatening disorders. Because of the complexity of the clinical situation when an obvious cause for syncope is not found, patients may be subjected to a significant period of hospitalization and a large number of diagnostic tests. Retrospective and prospective studies have shown that many diagnostic tests are frequently employed but are infrequently diagnostic of a cause of syncope. Thus, studies have shown that when a cause is established or suggested, the majority of diagnoses are assigned based on initial history and physical examination. An initial electrocardiogram is helpful in assigning a cause of syncope in only approximately five percent of additional patients. In a prior study prolonged electrocardiographic monitoring was helpful in assigning a cause of syncope in approximately fifteen percent of patients. Other studies of prolonged electrocardiographic monitoring in patients with syncope reveal that arrhythmias as a potential cause of syncope are found in eleven to sixty-four percent of patients. Diagnostic procedures such as EEG, head CT scan, brain scan, cerebral angiography, echocardiography, and cardiac catheterization rarely establish a cause of syncope but are useful when employed selectively for diagnosis of specific etiologies of syncope.

These studies of diagnostic evaluation of syncope, therefore, clearly indicate that there is a subgroup of patients with syncope who have arrhythmias as a cause of their syncope which were not apparent from initial history, physical examination, and EKG. Therefore, prolonged electrocardiographic monitoring has assumed a central role in the diagnostic evaluation of this group of patients for detection of arrhythmias. Because of the prognostic and therapeutic importance of arrhythmias causing syncope, it is important to identify patients who are likely to have arrhythmias from the data available at presentation. There were no studies prior to 1987 attempting to identify such patients at presentation. The predictors of diagnostic arrhythmias at presentation may be helpful for four reasons. First, the variables suggesting high likelihood of arrhythmias may provide a basis for decisions regarding the need for hospital admission. Secondly, predictors of diagnostic arrhythmias may identify patients who may need to be monitored immediately as opposed to electively. Thirdly, patients who have predictors of diagnostic arrhythmias may be more appropriate candidates for invasive diagnostic testing such as intracardiac electrophysiologic studies. Fourthly, since patients with arrhythmias are at high risk of sudden death, these predictors may identify an appropriate subset of patients for further studies involving therapeutic interventions. Since many patients with syncope have multiple risk factors for sudden death, the development of a multifactorial model to more effectively and expeditiously predict the degree of risk of sudden death may be important in the management of patients with syncope after initial presentation.

DESIGN NARRATIVE:

Two models were validated in this longitudinal study including one which predicted sudden death and one which predicted diagnostic arrhythmias on monitoring. The model for prediction of sudden death was developed in patients in whom a cause of syncope was not established by initial history and physical examination. The predictors in this model included a history of diabetes mellitus, renal insufficiency, left ventricular hypertrophy, left bundle branch block, and left axis deviation. The model of predictors of diagnostic arrhythmias was developed in patients in whom a cause of syncope was not established from initial history, physical examination, or EKG and included a history of ventricular tachycardia and an abnormal EKG by specific criteria.

Patients with syncope were accrued from the emergency room, the inpatient services and the ambulatory clinics of the Presbyterian University Hospital of Pittsburgh. All patients underwent a basic standardized evaluation consisting of a history, physical examination, baseline laboratory tests, electrocardiogram, prolonged electrocardiographic monitoring, and special diagnostic tests as necessary. Diagnosis of a cause of syncope was assigned by standardized criteria. Follow-up information regarding sudden death and mortality was obtained at three-month intervals until the end of the study. Causes of death were assigned in a standardized manner.

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 Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Cardiovascular Diseases
  • Arrhythmia
  • Death, Sudden, Cardiac
  • Heart Diseases
  • Syncope
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment Not Provided
Original Enrollment Not Provided
Actual Study Completion Date June 1992
Primary Completion Date Not Provided
Eligibility Criteria No eligibility criteria
Sex/Gender
Sexes Eligible for Study: Male
Ages up to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00005202
Other Study ID Numbers 1081
R01HL036735 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Heart, Lung, and Blood Institute (NHLBI)
Verification Date May 2000