NCT02959788

Brief Summary

Identification of patients who are at highest risk for heart attack is an important task for emergency medicine physicians. Currently, physicians use a variety of different scoring systems to stratify their risk for having a heart attack. Heart rate variability (HRV) is a measure derived from noninvasive cardiac monitoring. This data is collected from a simple, non-invasive chest strap during a 10-minute recording session. The purpose of this proposal is to collect heart rate variability data on patients admitted to the emergency department with chest pain. The intent is to measure the association between heart rate variability and the various risk stratification scoring systems for chest pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

4 months

First QC Date

November 7, 2016

Last Update Submit

February 10, 2017

Conditions

Acute Coronary Syndrome

Keywords

Heart rate variability

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac events

    30 days

Secondary Outcomes (2)

  • HEART score

    1 day

  • Coronary heart disease risk factors

    1 day

Study Arms (1)

Chest pain patients

All patients who present to the ED with chest pain.

Other: Heart rate variability

Interventions

Heart rate variabilityOTHER

All patients have a 10-minute recording analyzed for indices of heart rate variability.

Chest pain patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults who present to the emergency department with chest pain.

You may qualify if:

  • Chest pain in ED

You may not qualify if:

  • STEMI
  • Prisoners
  • Pregnant women
  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Nicholas M Mohr, MD, MS

    University of Iowa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 9, 2016

Study Start

April 1, 2016

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

February 14, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)