Haemodynamic Abnormalities Recorded With Cardiac Catheterization Along With Body's Surface Micro-accelerometers (KT-KCG)

Heart Failure Clinical Trial

— KT-KCG  

Official title:

Do Abnormal Hemodynamic Features Generate Relevant Reactions and Vibrations at the Skin Level When Recorded by Micro Accelerometers

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03821766
• Other study ID #: P2018/479
• Status: Withdrawn
• Start date: February 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2020
• Source: Erasme University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The ballistocardiography (BCG) and the seismocardiography (SCG) are old techniques recording the vibrations at the skin level generated by the acceleration and displacement of the blood and cardiac mass at each cardiac contraction. The former records the acceleration near the subject's center of mass, the latter at the local chest wall. So far, the unclear physiological origin of those acceleration signals has led to important ambiguities in their scientific and clinical interpretation. Therefore, several ongoing studies would aim to highlight the physiological genesis of those acceleration-induced signals.

Indeed, the main objective of this study is to correlate the BCG and SCG signals recorded at the body surface with several haemodynamic parameters recorded invasively during a cardiac catheterisation, pulmonary pressure, wedge pressure, cardiac output to cite a few.

Description:

Patients suffering from severe heart failure regardless of the etiology will undergo a cardiac catheterization as required by their medical condition.

The SCG and BCG signals will be recorded simultaneously to the catheterization by the mean of an unintrusive and friendly device consisting of two houses, the first one placed on sternum and the second one in the lumbar column. The device will record a continuous tracing synchronized with the intracavitary pressure profiles recorded during the invasive procedure.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18 y.o. to 80 y.o.

• Heart failure

Exclusion Criteria:

• Left ventricle assistance device

• Refused participation

Related Conditions & MeSH terms

• Heart Failure
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Device:
• Ballistocardiography and seismocardiography
SCG and BCG signals will be recorded by the mean of an unobtrusive and friendly device consisting of two houses, the first one placed on the sternum and the second one place on the lumbar region near the subject's center of mass. The signal will be transferred to a tablet by Bluetooth and tracings will be analysed automatically with Matlab. The SCG+BCG signals are synchronized to the intracardiac pressure tracings in order to allow a comparative interpretation between the two tracings.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erasme University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Micro-accelerations recorded at the body's surface	Analysis of heart-induced velocities (m/s) by the means of micro-accelerometers and secondary computation of the kinetic energy (KE= 1/2 mv²) recorded with the seismocardiography and ballistocardiography at the skin level during cardiac catheterization.	6 months