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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.

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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.

Trial Details

FieldValue
Enrollment Target 3,707 participants
Start Date 2013-04
Est. Completion 2016-12-14

Sponsor

University of Pennsylvania

1,423 total trials

What the Registry Record Tells You About NCT01802398

The ClinicalTrials.gov registry entry for NCT01802398 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 3,707 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT01802398 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.