Cardiovascular DiseasesNCT00005202
Identifying High Risk Patients With Syncope
An observational study of Cardiovascular Diseases and Arrhythmia, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Cardiovascular Diseases, Arrhythmia, Death, Sudden, Cardiac
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1987to Jun 1992
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Medical subject headings
- Cardiovascular Diseases, Arrhythmias, Cardiac, Death, Sudden, Cardiac, Heart Diseases, Syncope
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1987
- Study completionJun 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005202
- Sponsor's protocol ID
- 1081
- Other IDs
- R01HL036735
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 13 May 2016
- Results posted
- No
Publications
Kapoor WN, Cha R, Peterson JR, Wieand HS, Karpf M. Prolonged electrocardiographic monitoring in patients with syncope. Importance of frequent or repetitive ventricular ectopy. Am J Med. 1987 Jan;82(1):20-8. doi: 10.1016/0002-9343(87)90372-x.
PubMed 2432783Fine MJ, Kapoor W, Falanga V. Cholesterol crystal embolization: a review of 221 cases in the English literature. Angiology. 1987 Oct;38(10):769-84. doi: 10.1177/000331978703801007.
PubMed 3310742Martin DC, Miller J, Kapoor W, Karpf M, Boller F. Clinical prediction rules for computed tomographic scanning in senile dementia. Arch Intern Med. 1987 Jan;147(1):77-80.
PubMed 3800534Kapoor WN, Peterson J, Wieand HS, Karpf M. Diagnostic and prognostic implications of recurrences in patients with syncope. Am J Med. 1987 Oct;83(4):700-8. doi: 10.1016/0002-9343(87)90901-6.
PubMed 3674057Kapoor WN. Evaluation of syncope in the elderly. J Am Geriatr Soc. 1987 Aug;35(8):826-8. doi: 10.1111/j.1532-5415.1987.tb06364.x. No abstract available.
PubMed 3611575Martin DC, Miller JK, Kapoor W, Arena VC, Boller F. A controlled study of survival with dementia. Arch Neurol. 1987 Nov;44(11):1122-6. doi: 10.1001/archneur.1987.00520230012006.
PubMed 3675243Bankowitz R, Blumenfeld B, Bettinsoli N, Parker R, McNeil M, Challinor S, Massarie F, Kapoor WN, Arena V, Miller R: User Variability in Abstracting and Entering Patient Case Histories Using Quick Medical Reference (QMR). Proc 11th Ann Symp on Computer Applications in Medical Care, p 68-73, 1987
Kapoor W: Use of Electrophysiologic Studies in Unexplained Syncope. Pract Cardiol, 1113:53-63, 1987
Kapoor WN: Syncope and Hypotension. Emergency Decisions, 1987
Kapoor WN: Electrocardiographic Monitoring in Syncope. Cardiol Board Rev, 4:57-75, 1987
Bass EB, Elson JJ, Fogoros RN, Peterson J, Arena VC, Kapoor WN. Long-term prognosis of patients undergoing electrophysiologic studies for syncope of unknown origin. Am J Cardiol. 1988 Dec 1;62(17):1186-91. doi: 10.1016/0002-9149(88)90257-3.
PubMed 3195480Bankowitz RA, McNeil MA, Challinor SM, Parker RC, Kapoor WN, Miller RA. A computer-assisted medical diagnostic consultation service. Implementation and prospective evaluation of a prototype. Ann Intern Med. 1989 May 15;110(10):824-32. doi: 10.7326/0003-4819-110-10-824.
PubMed 2653156Kapoor WN, Hammill SC, Gersh BJ. Diagnosis and natural history of syncope and the role of invasive electrophysiologic testing. Am J Cardiol. 1989 Mar 15;63(11):730-4. doi: 10.1016/0002-9149(89)90260-9. No abstract available.
PubMed 2646899Bass EB, Curtiss EI, Arena VC, Hanusa BH, Cecchetti A, Karpf M, Kapoor WN. The duration of Holter monitoring in patients with syncope. Is 24 hours enough? Arch Intern Med. 1990 May;150(5):1073-8.
PubMed 2331188Kapoor WN. Evaluation and outcome of patients with syncope. Medicine (Baltimore). 1990 May;69(3):160-75. doi: 10.1097/00005792-199005000-00004.
PubMed 2189056
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying High Risk Patients With Syncope
- ClinicalTrials.gov ID
- NCT00005202
- Acronym / sponsor ID
- 1081
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1987
- Study completion
- Jun 1992 (actual)
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Background: PubMed 2432783Kapoor WN, Cha R, Peterson JR, Wieand HS, Karpf M. Prolonged electrocardiographic monitoring in patients with syncope. Importance of frequent or repetitive ventricular ectopy. Am J Med. 1987 Jan;82(1):20-8. doi: 10.1016/0002-9343(87)90372-x.
- Background: PubMed 3310742Fine MJ, Kapoor W, Falanga V. Cholesterol crystal embolization: a review of 221 cases in the English literature. Angiology. 1987 Oct;38(10):769-84. doi: 10.1177/000331978703801007.
- Background: PubMed 3800534Martin DC, Miller J, Kapoor W, Karpf M, Boller F. Clinical prediction rules for computed tomographic scanning in senile dementia. Arch Intern Med. 1987 Jan;147(1):77-80.
- Background: PubMed 3674057Kapoor WN, Peterson J, Wieand HS, Karpf M. Diagnostic and prognostic implications of recurrences in patients with syncope. Am J Med. 1987 Oct;83(4):700-8. doi: 10.1016/0002-9343(87)90901-6.
- Background: PubMed 3611575Kapoor WN. Evaluation of syncope in the elderly. J Am Geriatr Soc. 1987 Aug;35(8):826-8. doi: 10.1111/j.1532-5415.1987.tb06364.x. No abstract available.
- Background: PubMed 3675243Martin DC, Miller JK, Kapoor W, Arena VC, Boller F. A controlled study of survival with dementia. Arch Neurol. 1987 Nov;44(11):1122-6. doi: 10.1001/archneur.1987.00520230012006.
- BackgroundBankowitz R, Blumenfeld B, Bettinsoli N, Parker R, McNeil M, Challinor S, Massarie F, Kapoor WN, Arena V, Miller R: User Variability in Abstracting and Entering Patient Case Histories Using Quick Medical Reference (QMR). Proc 11th Ann Symp on Computer Applications in Medical Care, p 68-73, 1987
- BackgroundKapoor W: Use of Electrophysiologic Studies in Unexplained Syncope. Pract Cardiol, 1113:53-63, 1987
- BackgroundKapoor WN: Syncope and Hypotension. Emergency Decisions, 1987
- BackgroundKapoor WN: Electrocardiographic Monitoring in Syncope. Cardiol Board Rev, 4:57-75, 1987
- Background: PubMed 3195480Bass EB, Elson JJ, Fogoros RN, Peterson J, Arena VC, Kapoor WN. Long-term prognosis of patients undergoing electrophysiologic studies for syncope of unknown origin. Am J Cardiol. 1988 Dec 1;62(17):1186-91. doi: 10.1016/0002-9149(88)90257-3.
- Background: PubMed 2653156Bankowitz RA, McNeil MA, Challinor SM, Parker RC, Kapoor WN, Miller RA. A computer-assisted medical diagnostic consultation service. Implementation and prospective evaluation of a prototype. Ann Intern Med. 1989 May 15;110(10):824-32. doi: 10.7326/0003-4819-110-10-824.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Arrhythmia, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005202, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.