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

NCT ID: NCT03821766

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2020-12-30

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.

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.

Conditions

Heart Failure; Pulmonary Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Ballistocardiography and seismocardiography

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Left ventricle assistance device
• Refused participation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasme University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

P2018/479

Identifier Type: -

Identifier Source: org_study_id