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NCT01796704 Clinical Trial

Comparison of the Prediction Derived by the Cardiovascular Performance Reserve Index With the Clinical Evaluation

Healthy Clinical Trial

Official title:
Comparison of the Prediction Derived by the Cardiovascular Performance Reserve Index (Calculated From Physiological Parameters) With the Clinical Evaluation

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01796704
Other study ID # COM120018CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 29, 2013
Last updated February 21, 2013
Start date February 2013
Est. completion date March 2014

Study information
Verified date October 2012
Source Clalit Health Services
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

The study hypothesizes that an assumed cardiovascular performance reserve is physiologically detectable.

High reserve at rest characterizes a healthy person while low reserve at rest characterizes low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.

The reserve may be estimated through CVRI (cardiovascular reserve index) which is computed by an algorithm composed of physiological measurements taken during the patient visit.

In this study the investigators evaluate CVRI capability in prediction of functional capacity in comparison with the clinical evaluation during the same visit.

Description:

The study hypothesizes that an assumed cardiovascular performance reserve is physiologically detectable and continuously monitored by a physiological control (reserve control)not yet discovered.

High reserve at rest characterizes a healthy person while low reserve at rest characterizes low functional capacity e.g. heart failure. The lower the reserve the severer the morbidity.

The reserve is decreased reversibly with aerobic activity and may reach an exhaustion threshold in which the assumed reserve control induces a reversible fatigue and dyspnea which dissolve once the activity decreased.

The reserve may be estimated through CVRI (cardiovascular reserve index) which is computed by an algorithm composed of physiological measurements taken during the patient visit (composed of blood pressure, heart rate, respiratory rate, central venous pressure or its estimation, weight, height and gender.

In this study the investigators evaluate CVRI capability in prediction of functional capacity in comparison with the clinical evaluation during the same visit (cross sectional comparison).

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date March 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- adult informed consent

Exclusion Criteria:

- an emergency case

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Independent physician Clinic Clalit Health Services Tel Aviv

Sponsors (1)
Lead Sponsor Collaborator
Clalit Health Services

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary cardiovascular reserve index CVRI 1 day No
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