Coronary Artery Disease
Conditions
Keywords
coronary artery disease, diagnosis, non-invasive
Brief summary
This is a validation study comparing a pulse wave based algorithm for the detection of coronary artery disease with parameters from coronary angiography, echocardiography and cardiogoniometry.
Detailed description
The study will validate a pulse wave based algorithm for the detection of coronary artery disease (CAD) with parameters from standard methods. Subjects will be patients admitted to coronary angiography due to suspected CAD. Pulse wave signals will be analyzed according to novelly established algorithm regarding the presence of CAD and/or myocardial ischemia. These results be compared to the diagnoses made by coronary angiography (primary endpoint): presence of minimum one coronary artery stenose \>=50%. For secondary analyses, results will be compared to parameters form echocardiography and cardiogoniometry.
Interventions
Validation of a diagnostic algorithm used to detect coronary artery disease and/or myocardial ischemia based on pulse wave analyses.
Sponsors
Study design
Eligibility
Inclusion criteria
* Coronary angiography indication present * informed written consent
Exclusion criteria
* Previous coronary angiography * Known CAD (history of coronary angioplasty, stent implantation and/or bypass surgery) * atrial fibrillation (at time of measurement) * severe ventricular extrasystole (e.g. \>=10% ventricular extrasystoles, bigemina) * pregnancy, lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of CAD - angio (minimum 1 stenosis >=50%) | 1 day | Presence of CAD in coronary angiography: minimum 1 stenosis \>=50% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of CAD number - angio (Number of coronary vessels with at least 1 stenosis >=50% in coronary angiography) | 1 day | Number of coronary vessels with at least 1 stenosis \>=50% in coronary angiography |
| Wall motion abnormality - echo (Presence of wall motion abnormality in at least 1 segment (2D echocardiography) | 1 day | Presence of wall motion abnormality in at least 1 segment (2D echocardiography) |
| Wall motion index - echo (Wall motion index (2D and 3D echocardiography) | 1 day | Wall motion index (2D and 3D echocardiography) |
| Global longitudinal strain (2D and 3D echocardiography) | 1 day | Global longitudinal strain (2D and 3D echocardiography) |
| Abnormal cardiogoniometry | 1 day | Abnormal results of cardiogoniometry |
Countries
Germany