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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02959788
Other study ID # 201512751
Secondary ID
Status Completed
Phase N/A
First received November 7, 2016
Last updated February 10, 2017
Start date April 2016
Est. completion date August 2016

Study information

Verified date February 2017
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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.

The investigators propose to enroll patients admitted to the emergency department with chest pain. In addition to HRV data, clinical risk factors will be obtained, using validated clinical risk scoring systems. The team will follow patient's clinical course in order to include information about the determined cause of chest pain. The goal is to understand how HRV can augment common risk stratification scoring systems for patient presenting to the ED with chest pain.


Recruitment information / eligibility

Status Completed
Enrollment 62
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Chest pain in ED

Exclusion Criteria:

- STEMI

- Prisoners

- Pregnant women

- Unable to consent

Study Design


Intervention

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

Locations

Country Name City State
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Major adverse cardiac events 30 days
Secondary HEART score 1 day
Secondary Coronary heart disease risk factors 1 day
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