- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02422342
Comparison Study of Non-invasive Measurement of Blood Pressure and Cardiac Output During Stress Echocardiography
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
The HeartBeat system combines an FDA/CE approved watch-like Pulse Oximeter for acquiring the data and an android software application that serves as the Hemodynamic calculator. The application performs POST-PROCESSING of the PhotoPlethismoGraphic (PPG) signal (Normally the PPG signal in Pulse Oximeters is used only to compute heart rate and SpO2). The raw data is transferred from the watch oximeter to the smartphone using a standard Bluetooth protocol.
The Post-processing uses wavelet signal processing to estimate and display certain Hemodynamic parameters like Blood Pressure (BP) and Cardiac Output (CO) in a continuous and graphical way on a standard Android device. In addition to the standard heart rate and SpO2, the application displays the measured PPG signal and estimated continues BP and CO.
HeartBeat is the only device that can non-invasively estimate Continuous BP and its Cardiac Output component and the resistance component in a mobile wearable device. Differentiating between these 2 components can play a major role in helping the doctor to understand the effect of cardiovascular medications and Lifestyle interventions.
The trial will compare blood pressure and cardiac output parameters measured during Stress Echocardiography using an echo cardiograph and standard sphygmomanometer to the parameters generated by the application.
Trial goals
- Feasibility tests for the HeartBeat application as a tool for monitoring BP and CO changes over time
- Compare BP and CO parameters generated by the applications to the ones measured by standard non-invasive equipment during a Stress Echocardiography
- Calculate additional parameters such as stroke volume, systematic vascular resistance and cardiac index
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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-
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Kfar Saba, Israel, 4428164
- Meir health center
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients referred to an Stress Echocardiography test for cardiac diagnostics
- Male and Female
- Between 18 to 90 years old
Exclusion Criteria:
- Under the age of 18 or over 90 years old
- Patients in Shock
- Patients with Moderate or Severe valvular disease
- Patients with severe sepsis
- Inadequate jurisprudence patients
- Patients supported by Amines
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Cardiac Output
Tidsram: Change from Baseline in Cardiac Output at 30 minutes
|
Measurement of Cardiac Output at the beginning and the end of the test (30 minutes)
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Change from Baseline in Cardiac Output at 30 minutes
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Blood Pressure
Tidsram: Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes
|
Change from Baseline in Systolic and Diastolic blood pressure at 30 minutes
|
|
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Heart rate
Tidsram: Change from Baseline in heart rate at 30 minutes
|
Measurement of Systolic and Diastolic blood pressure at the beginning and the end of the test
|
Change from Baseline in heart rate at 30 minutes
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Yoram Neuman, MD, Meir Health Facility
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HeartBeat_V2.0_SE
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