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

Ischemic Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02530021
• Other study ID #: 0036-15
• Status: Recruiting
• Phase: N/A
• First received: August 19, 2015
• Last updated: March 14, 2016
• Start date: August 2015
• Est. completion date: November 2016

Study information

• Verified date: March 2016
• Source: Meir Medical Center
• Contact: Yoav Arnson, MD
• Phone: 97297472120
• Email: yoav.arnson[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar-Sava

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Correlation between Heart rate variability and invasive angiography	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	No