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NCT01802398 · ClinicalTrials.gov registry record
Improving Syncope Risk Stratification in Older Adults
A clinical trial, sponsored by University of Pennsylvania.
- Completed
- Registry status
- 3,707
- Enrollment target
NCT01802398: Completed study, sponsored by University of Pennsylvania.
NCT01802398 is a clinical trial that has completed, run by University of Pennsylvania. The registered enrollment target is 3,707 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01802398 has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- 3,707 participants
- Enrollment target
Study Summary
Syncope (temporary loss of consciousness) is a frequent reason for an emergency department (ED) visit among older adults. The current ED evaluation of syncope frequently leads to hospitalization, results in low diagnostic yield, and is enormously costly. The purpose of this protocol is to improve risk prediction for syncope. Improved risk prediction will inform the design of interventions to safely reduce unnecessary health service use. This is a multi-center, prospective, observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting). The primary outcome is a composite of 30-day cardiac death and serious cardiac events. Study Aims and Hypotheses are: Specific Aim 1. Describe serious outcomes after unexplained syncope; rates and reasons for admission; and frequency, diagnostic yield, and therapeutic impact of inpatient diagnostic tests. H1: Current patterns of care representing a diversity of practice settings and patient populations are costly with low clinical benefit. Specific Aim 2. Derive and validate a novel risk prediction model for 30-day cardiac death and serious cardiac outcomes after unexplained syncope. H2: Explicit criteria including contemporary cardiac biomarkers will improve risk stratification compared to unstructured physician assessment and published risk models. Specific Aim 3. Assess safety and costs of a risk-tailored diagnostic algorithm compared to existing care for unexplained syncope. H3: A risk-tailored diagnostic algorithm can safely reduce the costs of evaluating unexplained syncope in older adults.
Primary Outcome
This aim tests the hypothesis that current patterns of care are costly with low clinical benefit. We will generate tables that describe the demographics, clinical characteristics, and disposition of the study cohort, stratified by occurrence of the primary outcome. Outcomes experienced by the study cohort will be described in detail.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,707 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-12-14 |
What the finished NCT01802398 record still lists
NCT01802398 is an observational study that tracks outcomes without assigning an intervention. Its 3,707 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01802398 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01802398 about?
NCT01802398 is a clinical study titled "Improving Syncope Risk Stratification in Older Adults". Syncope (temporary loss of consciousness) is a frequent reason for an emergency department (ED) visit among older adults. The current ED evaluation of syncope frequently leads to hospitalization, results in low diagnostic yield, and is enormously costly. The purpose of this protocol is to improve ri...
What is the current status of trial NCT01802398?
This trial is currently completed. The enrollment target is 3,707 participants. The study started on 2013-04. Estimated completion is 2016-12-14.
Who is sponsoring clinical trial NCT01802398?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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