Haemodynamic Abnormalities Recorded With Cardiac Catheterization Along With Body's Surface Micro-accelerometers (KT-KCG) (KT-KCG)
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|ClinicalTrials.gov Identifier: NCT03821766|
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : October 9, 2019
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|
|Heart Failure Pulmonary Hypertension||Device: Ballistocardiography and seismocardiography|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Do Abnormal Hemodynamic Features Generate Relevant Reactions and Vibrations at the Skin Level When Recorded by Micro Accelerometers|
|Estimated Study Start Date :||February 1, 2020|
|Estimated Primary Completion Date :||September 1, 2020|
|Estimated Study Completion Date :||December 30, 2020|
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.
- Micro-accelerations recorded at the body's surface [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821766
|Contact: Sofia Morra, MD, PhD fellow||+32 2 555 59 email@example.com|