Data Acquisition for Optimization of Coronary Artery Disease (CAD) Algorithm

Acarix

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: CADScor1

Study type: Observational

Funder types: Industry

Identifiers

NCT01564628

AC003-SH

Details and patient eligibility

About

The purpose of the study is to optimize an already existing algorithm for diagnosing atherosclerosis of the coronary arteries (CAD, Coronary Artery Disease).

Full description

Acoustic information from the heart is obtained from patients referred to examination for Coronary Artery Disease. The acoustic signals are evaluated as indicators for CAD.

Enrollment: 306 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 18 years old
• Referred to diagnostically Ca-CT, CT scan and/or CAG examination due to suspicion of coronary artery disease
• Subjects condition must be stable and the subject must not be referred due to suspicion of acute coronary syndrome
• Subject is willing to adhere to the study procedure
• Has signed the informed consent form and authorization to registration and publication of health information

Exclusion criteria

• Has acute coronary syndrome or stroke
• Arterial fibrillation
• Known severe arrhythmia or resting heart rate above 85 bpm
• Known diastolic murmurs due to heart valve disease
• Has had a previous by-pass operation, open chest surgery, donor heart or mechanical heart
• Reduced ejection fraction < 50%
• Inability to understand or adhere to instructions for acoustic Data-acquisition (i.e. subject not able to hold breath due to KOL or asthma)
• Inability to perform CT-angio and/or subsequent CAG
• In active treatment for any cancer
• In active treatment for immunosuppression after transplantation
• Established or pursuing pregnancy or breast feeding
• Has damaged skin on the spot where the patch is placed during the recordings.

Trial design

306 participants in 1 patient group

All study participants

Description:

Population from 2 sites, sequential design with all patients undergoing CADScor1 intervention followed by the diagnostic testing the patients were referred to (procedure done according to standard of care and not part of study; computerized tomographic angiography (CTA) and, if relevant, coronary angiography (CAG) at Site 1 and CAG at site 2).

Treatment:

Device: CADScor1