Indication for coronary multi-detector computed tomographic angiography
Conditions
Sponsors
Bracco ALTANA Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Indication for coronary MD-CTA; - Patient is adult (> or = 18 years), conscious and co-operative; - Bodyweight between 60 and 124 kg; - Written Informed Consent to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Known multivessel or diffuse CAD; 2. Arrhythmia; 3. Patient is unable to hold breath; 4. Any medical condition or other circumstances that would significantly decrease the chances of obtaining reliable data or of achieving the study objectives according to the investigator’s final opinion; 5. Hyperthyreosis (TSH below 0.3 mU/l); 6. Renal insufficiency (serum creatinine > 1.5 mg/dl, or > 130µmol/l); 7. Hypersensitivity to iodinated contrast media, or allergic disposition; 8. Insulin Dependent Diabetes Mellitus (IDDM); 9. Patient is currently participating or has previously participated in a clinical trial (in which an investigational drug was dispensed) within 30 days prior to admission to this study; 10. Previous participation in this clinical trial; 11. Alcohol or drug abuse; 12. Patient is female and pregnant or nursing; 13. Patient is female and the possibility of pregnancy cannot be excluded 14. Patient is institutionalized by law
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficiency of a body weight-adapted bolus administration of a medium concentration (Iomeprol 300) contrast agent, providing medium iodine flux, versus a high concentration (Iomeprol 400) contrast agent, providing high iodine flux, for visualization of the length of the coronary arteries in MDCTA, expressed as percentage of total automated segmentation length in relation to total manually measured segment length;Secondary Objective: To compare between the medium iodine flux group (Iomeprol 300) and the high iodine flux group (Iomeprol 400) To explore the correlation between body-weight and contrast density and between body weight and visualization of coronary segments (length and number of segments);Primary end point(s): The primary efficacy variable is the percentage of total automated segmentation length in relation to total manually measured segment length: %SL = (TSLautomated segmentation) x 100 / TSLmanual segmentation Where: %SL = Percentage of segment length TSL = Total length of segments determined [mm] The percentage of total automated segmentation length will be compared between study groups by means of a WILCOXON MANN-WHITNEY U test. | — |
Countries
Germany
Outcome results
None listed