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

NCT ID: NCT02530021

Last Updated: 2016-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-11-30

Brief Summary

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.

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.

Conditions

Angina Pectoris; Ischemic Heart Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Heart rate monitor

Intervention Type: OTHER

One hour non-invasive ECG heart rate variability monitoring. The results will be blinded and interpreted independantly. Study results will not effect patient management.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Arnson Yoav

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoav Arnson, MD

Role: PRINCIPAL_INVESTIGATOR

Mei Medical Center

Locations

Meir Medical Center

Kfar Saba, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Yoav Arnson, MD

Role: CONTACT

yoav.arnson@gmail.com

97297472120

Olga Zyabkin, MD

Role: CONTACT

97297472120

Facility Contacts

Yoav Arnson

Role: primary

References

Harris PR, Stein PK, Fung GL, Drew BJ. Heart rate variability measured early in patients with evolving acute coronary syndrome and 1-year outcomes of rehospitalization and mortality. Vasc Health Risk Manag. 2014 Aug 5;10:451-64. doi: 10.2147/VHRM.S57524. eCollection 2014.

Reference Type: BACKGROUND

PMID: 25143740 (View on PubMed)

Other Identifiers

0036-15

Identifier Type: -

Identifier Source: org_study_id