Prospective, consecutive, blinded, clinical investigation validating the performance of the CADScor System against invasive coronary angiography in subjects with symptoms of stable CAD referred for invasive coronary angiography

Prospective, consecutive, blinded, clinical investigation validating the performance of the CADScor System against invasive coronary angiography in subjects with symptoms of stable CAD referred for invasive coronary angiography - VALIDATE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00010492

Enrollment

200

Registered

2016-06-23

Start date

2016-04-27

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

I25.0

Interventions

Group 1: The CADScor® System is an approved medical device and indicated for use as an acoustic decision support tool for diagnosing patients suspected of coronary artery disease. In this trial the pe

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: 40 years or older; Symptoms of stable CAD; Referred for diagnostic ICA; Be able and willing to comply with the clinical investigational plan; Have signed the informed consent from;

Exclusion criteria

Exclusion criteria: 1. Acute coronary syndromes (ACS) 2. CADScor System contraindications a. Previous Coronary Artery Bypass Graft (CABG) b. Previous Coronary stenting c. Arrhythmia causing non-sinus rhythm d. Implanted mechanical heart valve e. Diastolic murmurs f. Implanted donor heart or mechanical heart g. Implanted mechanical heart pump h. Implanted Pacemaker or Cardioverter Defibrillator (ICD) i. Implanted electronic equipment in the area above and around the heart j. Significant operation scars k. Fragile or compromised skin l. Abnormal body shape in the IC4L-recording area 3. ICA contraindications m. Usual care contraindications for ICA will be used in the study 4. FFR contraindications n. Usual care contraindications for FFR will be used in the study

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy (sensitivity and specifity to detect or exclude a >50% diameter stenosis) of the CADScor System using invasive coronary angiography (ICA) as a reference in a large cohort of patient referred to ICA with symptoms suggestive of stable coronary disease	—

Secondary

Measure	Time frame
Diagnostic accuracy of the CADScor System using fractional flow reserve (FFR) as a reference in a large cohort of patient referred to ICA with symptoms suggestive of stable coronary disease	—

Countries

Germany

Contacts

Public ContactTimm Bauer

Universitätsklinikum Gießen und Marburg GmbH, Med. Klinik I, Abteilung für Kardiologie/Angiologie

Timm.Bauer@innere.med.uni-giessen.de0641-985-42635

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026