Ignite Creation Date:
2024-05-06 @ 2:21 PM
Last Modification Date:
2024-10-26 @ 1:29 PM
Study NCT ID:
NCT04290091
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-03
First Post:
2020-02-25
Brief Title:
Detection of Coronary Artery Disease With Micro Electro-Mechanical Sensors
Sponsor:
Precordior Ltd
Organization:
Precordior Ltd
Study Overview
Official Title:
Detection of Coronary Artery Disease With Micro Electro-Mechanical Sensors
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DECADE
Brief Summary:
This study aims to validate the sensor data of gyroscope and accelerometer in detection of hemodynamically significant CAD
Detailed Description:
Heart diseases are the most common cause of morbidity and mortality in the western world Coronary artery disease CAD alone is estimated to affect 110 million people globally and resulted in 89 million deaths in 2015
A hallmark phenomenon in the development of CAD is the formation of arterial stenoses eventually limiting the arterial circulation Myocardial ischemia caused by the stenoses may present symptoms considered typical ie angina pectoris chest pain but the symptoms may vary up to an asymptomatic state Estimating the pre-test likelihood of angiographically significant CAD 50 diameter stenotic CAD is a fundamental component in the initial evaluation of symptomatic patients presenting with suspected CAD This determination directly influences subsequent decisions for noninvasive diagnostic testing and treatment However studies have shown a relatively low prevalence of either ischemia or obstructive CAD on noninvasive imaging and invasive angiography IA in this population Therefore additional methods are needed to improve patient selection for such testing
Mechanocardiography MCG assesses the condition of the heart by measuring the mechanical activity cardiac muscle motion of the heart from the surface of thorax MCG can be measured with accelerometer and gyroscope which react to recoil and vibration caused my cardiac contraction
This study aims to validate how the gyroscope and accelerometer derived parameters can identify patients with hemodynamically significant CAD in combined contrast computed tomography CT coronary angiography and positron emission tomography PET perfusion imaging in combination of high-sensitive troponin testing The performance of different MCG algorithms will be tested offline as a head-to-head comparison with medical history cardiovascular events high-sensitive troponin values coronary computed tomography angiography CCTA and PET scan results
A hallmark phenomenon in the development of CAD is the formation of arterial stenoses eventually limiting the arterial circulation Myocardial ischemia caused by the stenoses may present symptoms considered typical ie angina pectoris chest pain but the symptoms may vary up to an asymptomatic state Estimating the pre-test likelihood of angiographically significant CAD 50 diameter stenotic CAD is a fundamental component in the initial evaluation of symptomatic patients presenting with suspected CAD This determination directly influences subsequent decisions for noninvasive diagnostic testing and treatment However studies have shown a relatively low prevalence of either ischemia or obstructive CAD on noninvasive imaging and invasive angiography IA in this population Therefore additional methods are needed to improve patient selection for such testing
Mechanocardiography MCG assesses the condition of the heart by measuring the mechanical activity cardiac muscle motion of the heart from the surface of thorax MCG can be measured with accelerometer and gyroscope which react to recoil and vibration caused my cardiac contraction
This study aims to validate how the gyroscope and accelerometer derived parameters can identify patients with hemodynamically significant CAD in combined contrast computed tomography CT coronary angiography and positron emission tomography PET perfusion imaging in combination of high-sensitive troponin testing The performance of different MCG algorithms will be tested offline as a head-to-head comparison with medical history cardiovascular events high-sensitive troponin values coronary computed tomography angiography CCTA and PET scan results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None