Heart Rate Variability as a Predictor of Ischemic Heart D... | NCT02959788

Studies
Heart Rate Variability as a Predictor of Ischemic Heart Disease

NCT02959788

Sponsor

University of Iowa

Status

Completed

Last Update Posted

Feb 14, 2017Actual

Enrollment

62Actual

Phase

Not provided

Conditions

Acute Coronary Syndrome

Interventions

Heart rate variability

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016Actual

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Nov 7, 2016

First Submission Date that Met QC Criteria

Nov 7, 2016

First Posted Date

Nov 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2017

Last Update Posted Date

Feb 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohr, Nicholas M, Associate Professor, University of IowaPrincipal Investigator

Lead Sponsor

University of IowaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Chest pain patients		All patients who present to the ED with chest pain.	Other: Heart rate variability

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Heart rate variability	Other	All patients have a 10-minute recording analyzed for indices of heart rate variability.	Chest pain patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major adverse cardiac events		30 days

Secondary Outcomes

Measure	Description	Time Frame
HEART score		1 day
Coronary heart disease risk factors		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chest pain in ED

Exclusion Criteria:

STEMI
Prisoners
Pregnant women
Unable to consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicholas M Mohr, MD, MS	University of Iowa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Iowa Hospitals and Clinics		Iowa City	Iowa	52242	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided