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

NCT02530021 | Unknown DMC

• 1 other identifier: 0036-15
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Angina Pectoris; Ischemic Heart Disease

Keywords

Ischemic heart disease; Heart rate variability; Exercise Strss Test

Outcome Measures

Primary Outcomes (1)

• Correlation betwen Heart rate variability test and non-onvasive testing

  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 Outcomes (1)

• Correlation between Heart rate variability and invasive angiography

  Time from non-invasive testing to coronary angiography. Estimated up to 5 days

Study Arms (1)

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

Interventions

Heart rate monitor 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.

Heart rate monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospitalized patients with suspected ischemic heart disease requiring further evaluation.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

Related Publications (1)

• 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.

  PMID: 25143740 BACKGROUND

MeSH Terms

Conditions

Angina Pectoris; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yoav Arnson, MD

  Mei Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoav Arnson, MD

CONTACT

97297472120; yoav.arnson@gmail.com

Olga Zyabkin, MD

CONTACT

97297472120

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 19, 2015
• First Posted: August 20, 2015
• Study Start: August 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 16, 2016

Record last verified: 2016-03

Locations

IL (1)