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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
Sponsor:
Information provided by (Responsible Party):
Erasme University Hospital

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
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.

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Study Type : Observational
Estimated Enrollment : 100 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
Estimated Study Start Date : February 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort 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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients suffering from heart failure and undergoing a planned cardiac catheterization as required by their medical condition will be asked to participate to the study.

The inclusion criteria include heart failure regardless of its etiology. Patients with a left ventricle assistance device will not be enrolled because the high-frequency accelerations generated by the mechanical device and transmitted to the skin level will likely hamper the ballisto- and seismocardiographic signal.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Left ventricle assistance device
  • Refused participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821766


Contacts
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Contact: Sofia Morra, MD, PhD fellow +32 2 555 59 19 sofia.morra@erasme.ulb.ac.be

Sponsors and Collaborators
Erasme University Hospital
  Study Documents (Full-Text)

Documents provided by Erasme University Hospital:
Study Protocol  [PDF] January 25, 2019

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Responsible Party: Erasme University Hospital
ClinicalTrials.gov Identifier: NCT03821766    
Other Study ID Numbers: P2018/479
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erasme University Hospital:
Intracavitary pressure
Ballistocardiography
Seismocardiography
Microaccelerations
Kinetic energy
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases