Heart Rate Variability (HRV) Testing Compared With Exercise Stress Test in Hospitalized Patients With Chest Pain

March 14, 2016 updated by: Arnson Yoav, Meir Medical Center

Sixty Minutes Heart Rate Variability Testing Compared With Non-invasive Exercise Stress Test in Hospitalized Patients With Suspected Angina Pectoris

There are many patients hospitalized for chest pain, which don't have high risk features that require invasive coronary angiography, but are considered intermediate risk and for which ischemic heart disease can not be excluded.

The current management for these patients is to perform a non invasive test in order to classify their risk.

Exercise ergometry is a commonly used non invasive test to detect ischemia. that test is non-invasive, and does not involve radiation or intra-venous contrast. The test is limited for many patients, because of un-ability to exercise, or because of non-interpetable Electro Cardio-Graphy (ECG).

Heart rate variability is well known to be a marker of ischemic heart disease. Heart rate variability testing is a non-invasive ECG monitoring technique.

The study design is to identify hospitalized patients who are candidates for non-invasive stress testing, and to monitor their heart rate variability for one hour prior to the stress test.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Ischemic heart disease is among the leading causes of death and disability in the modern world. Effective treatment for cardiac ischemia is based on identification of the proper patients and assigning prompt treatment to those patients.

It is not simple identifying the proper patients. There are many patients complaining of typical anginal chest pain without coronary heart disease, and there are many patients with active angina who complain of non-typical symptoms or who don't feel any symptoms.

Management of hospitalized patients with suspected angina pectoris is based on their complaints, their risk factors and laboratory results (ECG, troponin). They are classified into low-risk, high risk and intermediate.

Intermediate risk patients usually require additional testing in the hospital in order to re-classify them into high or low risk.

Heart rate variability is a well-known marker of active cardiac ischemia. The investigators plan to perform a 60 minute heart rate variability monitoring.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar-Sava, Israel
        • Recruiting
        • Meir Medical Center
        • Contact:
          • Yoav Arnson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospitalized patients with suspected ischemic heart disease requiring further evaluation.

Description

Inclusion Criteria:

  • Adult patients
  • Hospitalized for Chest pain
  • Intermediate probability for ischemic heart disease
  • Selected management strategy is non invasive cardiac stress testing

Exclusion Criteria:

  • Active Ischemic symptoms
  • ECG changes suggestive of myocardial ischemia
  • Troponin elevation on blood tests
  • Atrial flutter
  • Multiple APB's or VPB's on resting ECG

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Heart rate monitor

Hospitalized patients with chest pain and suspected ischemic heart disease who are candidates for non invasive exercise stress test by their treating physician.

The patients will perform a one hour heart rate variability monitoring prior to the stress test.
Other: Heart rate monitor
One hour non-invasive ECG heart rate variability monitoring. The results will be blinded and interpreted independantly. Study results will not effect patient management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation betwen Heart rate variability test and non-onvasive testing
Time Frame: The time from non-invasive testing to hospital discharg. Estimated up to 5 Days
Heart rate variability results will be compared to non-invasive test results ordered as routine care by treating physician.
The time from non-invasive testing to hospital discharg. Estimated up to 5 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between Heart rate variability and invasive angiography
Time Frame: Time from non-invasive testing to coronary angiography. Estimated up to 5 days
Patients which will undergo invasive angiography as part of selected management strategy will be compared with Heart rate variability test results.
Time from non-invasive testing to coronary angiography. Estimated up to 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Investigators

  • Principal Investigator: Yoav Arnson, MD, Mei Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

November 1, 2016

Study Registration Dates

First Submitted

August 19, 2015

First Submitted That Met QC Criteria

August 19, 2015

First Posted (Estimate)

August 20, 2015

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0036-15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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