Improving Syncope Risk Stratification in Older Adults (SRS)

This study is currently recruiting participants.
Verified April 2013 by Oregon Health and Science University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Benjamin Sun, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01802398
First received: February 27, 2013
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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.


Condition
Syncope

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Syncope Risk Stratification in Older Adults

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Combined death and serious cardiac events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Non-cardiac serious events [ Time Frame: 30-days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum samples will be collected for standardized cardiac biomarker testing. Samples will be split into two aliquots for testing and long-term storage. Aliquots in long-term -80˚C storage will be used for future studies of novel tests.


Estimated Enrollment: 3700
Study Start Date: April 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment
Observational cohort study of older (age≥60 years) adults who present to an emergency department with syncope (otherwise known as fainting)

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Emergency Departments (ED)

Criteria

Inclusion Criteria:

  1. age≥60 years; AND
  2. a complaint of syncope or near-syncope. Syncope is defined as a transient loss of consciousness (LOC), associated with loss of postural tone, with immediate, spontaneous, and complete recovery. Near-syncope is the sensation of imminent syncope without loss of consciousness.

Exclusion Criteria:

  • Seizure as presumptive cause of LOC
  • Stroke or transient ischemic attack as presumptive cause of LOC
  • LOC AFTER head trauma Confusion from baseline mental status
  • Intoxicated (alcohol or other drugs)
  • Medical or electrical intervention to restore consciousness
  • Hypoglycemia as presumptive cause of LOC
  • inability to provide follow-up information, including patients who do not speak English (or Spanish, if applicable for study site), lack phone access, or lack a permanent address
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802398

Contacts
Contact: Benjamin C Sun, MD 503-494-1193 sunb@ohsu.edu

Locations
United States, New York
URMC, Emergency Department Recruiting
Rochester, New York, United States, 14642
Contact: Manish Shah, MD       manish_shah@urmc.rochester.edu   
Contact: Nancy Wood, MS    585.276.6565    nancy_wood@urmc.rochester.edu   
Principal Investigator: Manish Shah, MD         
United States, North Carolina
Wakeforest, Department of Emergency Medicine Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Bret Nicks, MD       bnicks@wfubmc.edu   
Contact: Lori Triplett       ltriplet@wakehealth.edu   
Principal Investigator: Bret Nicks, MD         
United States, Ohio
Summa Health System, Department of Emergency Medicine (Research) Recruiting
Akron, Ohio, United States, 44304
Contact: Scott Wilber, MD       wilbers@summahealth.org   
Contact: Jennifer Frey, PhD    (330) 375-7530    freyja@summahealth.org   
Principal Investigator: Scott Wilber, MD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97229
Contact: Benjamin C Sun, MD    503-494-1193    sunb@ohsu.edu   
Contact: Marie-Annick N Yagapen, BS, CCRP    503-494-0649    yagapenm@ohsu.edu   
Principal Investigator: Benjamin C Sun, MD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Benjamin C Sun, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Benjamin Sun, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01802398     History of Changes
Other Study ID Numbers: NIH R01 HL111033-01A1
Study First Received: February 27, 2013
Last Updated: April 30, 2013
Health Authority: United States: Office for Human Research Protections (OHRP).

Keywords provided by Oregon Health and Science University:
Risk Stratification
Syncope
Geriatric

Additional relevant MeSH terms:
Syncope
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014