Clinical utility of the acoustic detection of coronary stenosis as early rule-out system – a blinded comparison to standard care

Clinical utility of the acoustic detection of coronary stenosis as early rule-out system – a blinded comparison to standard care - AKUSTIK

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00016986

Enrollment

500

Registered

2019-03-22

Start date

2019-04-17

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

I25.19

Interventions

Group 1: Patients with chest pain will have a blinded heart sound recording performed in addition to the initial standard evaluation including assessment of clinical history, echocardiography, resting

Eligibility

Sex/Gender

All

Age

40 Years to No maximum

Inclusion criteria

Inclusion criteria: • Males and females, aged 40 years or above. • Symptoms suggestive of stable CAD. • Having indication for further evaluation of suspected CAD • Have signed the informed consent form.

Exclusion criteria

Exclusion criteria: • Known CAD (previous myocardial infarction, angiographical CAD diagnosis and/or previous PCI and/or previous CABG) • DF score>85% • Acute Coronary syndrome • Implanted donor heart, mechanical heart, mechanical heart pump. • Pacemaker, Cardioverter Defibrillator (ICD) or other implanted electronic equipment in the area above and around the heart. • Significant operation scars, abnormal body shape, fragile or compromised skin in the fourth left intercostal space recording area. • Same day vaso-dilating drugs (e.g. nitroglycerine) prior to CAD-scoring. • Missing informed consent

Design outcomes

Primary

Measure	Time frame
Comparison of: 1) Actual proportion of patients ruled out after initial standard evaluation and 2) Simulated proportion of patients ruled out by a CAD-score =20, if the CAD-score was applied as the first rule-out test	—

Secondary

Measure	Time frame
In patients where the initial evaluation indicated further testing: 1) Actual cumulative number of downstream non-invasive and invasive tests until diagnosis (CAD/non-CAD) 2) Simulated cumulative number of downstream non-invasive and invasive tests until diagnosis (CAD/non-CAD), assuming that patients with a CAD-score =20 and thus avoided downstream non-invasive and invasive tests. 3) Actual number of negative ICAs performed. 4) Simulated number of negative ICAs performed, assuming that patients with a CAD-score =20 were ruled out and thus avoided downstream testing. 5) Prevalence of obstructive CAD in the subset of patients with a CAD-score =20. In patients ruled out after the initial evaluation: 1) Proportion of CAD-scores =20 versus >20 in patients experiencing an event during 6 months follow-up	—

Measure

Time frame

In patients where the initial evaluation indicated further testing: 1) Actual cumulative number of downstream non-invasive and invasive tests until diagnosis (CAD/non-CAD) 2) Simulated cumulative number of downstream non-invasive and invasive tests until diagnosis (CAD/non-CAD), assuming that patients with a CAD-score =20 and thus avoided downstream non-invasive and invasive tests. 3) Actual number of negative ICAs performed. 4) Simulated number of negative ICAs performed, assuming that patients with a CAD-score =20 were ruled out and thus avoided downstream testing. 5) Prevalence of obstructive CAD in the subset of patients with a CAD-score =20. In patients ruled out after the initial evaluation: 1) Proportion of CAD-scores =20 versus >20 in patients experiencing an event during 6 months follow-up

—

Countries

Germany

Contacts

Public ContactRalf Birkemeyer

Studienzentrum der Herzklinik Ulm

ralf.birkemeyer@herzklinik-ulm.de07319353070

Outcome results

None listed

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