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Completed

NCT Number: NCT04290091

Detection of Coronary Artery Disease With Micro Electro-Mechanical Sensors

This study aims to validate the sensor data of gyroscope and accelerometer in detection of hemodynamically significant CAD.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Turku University Hospital

Turku, 20520, Finland

About this study

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 8.9 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, i.e, 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Patients visiting hospital for suspected CAD and undergoing CCTA
  • Signed informed consent as an acceptance to participate to the trial

Exclusion criteria

  • informed consent not signed

Treatment and study plan

Primary outcomes

  1. Coronary artery disease

    Time frame: Time of enrolment

    CCTA results with optional myocardial PET perfusion imaging

Secondary outcomes

  1. Coronary artery disease event

    Time frame: 1 year after enrolment to the study

    Registry search of hospitalisation due to cardiovascular events

  2. Coronary artery disease event

    Time frame: 2 year after enrolment to the study

    Registry search of hospitalisation due to cardiovascular events

Sponsors and collaborators

Lead sponsor

Precordior Ltd

Industry

Registry information

Acronym: DECADE

Important dates

Study start
2020
Primary completion
2021
Study completion
2023
First posted
Feb 28, 2020
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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