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

Sponsor

Erasme University Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03821766

Collaborator

(none)

Enrollment

10.9

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Pulmonary Hypertension	Device: Ballistocardiography and seismocardiography

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Heart failure Patients suffering from heart failure regardless to the etiology will undergo cardiac catheterization according to their medical condition. the SCG and BCG signals will be recorded along with the intracavitary pressure profiles detected invasively with the cardiac catheterization.	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.

Arm

Intervention/Treatment

Heart failure

Patients suffering from heart failure regardless to the etiology will undergo cardiac catheterization according to their medical condition. the SCG and BCG signals will be recorded along with the intracavitary pressure profiles detected invasively with the cardiac catheterization.

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.

Outcome Measures

Primary Outcome Measures

Micro-accelerations recorded at the body's surface [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 y.o. to 80 y.o.
Heart failure

Exclusion Criteria:

Left ventricle assistance device
Refused participation

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Erasme University Hospital

Investigators

None specified.

Study Documents (Full-Text)

Study Protocol - Jan 25, 2019

More Information

Publications

None provided.

Responsible Party:

Erasme University Hospital

ClinicalTrials.gov Identifier:

NCT03821766

Other Study ID Numbers:

P2018/479

First Posted:

Jan 30, 2019

Last Update Posted:

Aug 25, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Erasme University Hospital

Intracavitary pressure

Additional relevant MeSH terms:

Hypertension, Pulmonary

Study Results

No Results Posted as of Aug 25, 2020