coronary artery stenosis narrowed coronary artery
Conditions
Interventions
None listed
Sponsors
Isala Klinieken
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - referred to Isala for a clinically indicated CAG procedure - suspected coronary artery disease (CAD) - signed informed consent
Exclusion criteria
Exclusion criteria: -age 30 - patients with diabetes mellitus - patients with known contrast agent intolerance - patients who underwent coronary artery bypass grafting - patients with cardiogenic shock - patients with heart failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: the mean image quality score of the research protocol, determined from a subjective judgement by cardiologists, is not lower by more than 0.2 points compared with the mean image quality score of clinical protocol (non-inferiority test). See section 3.3 of the protocol for the statistical analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint: the mean image quality score is computed off-site by measuring the CNR in a vessel in the research and reference runs. With the outcome of these measurements, the CNR will be correlated with the subjectively scored image quality. The objective is to determine the minimal required CNR. | — |
Countries
Netherlands
Outcome results
None listed