patients affected by cardiac pathology MedDRA version: 9.1 Level: SOC Classification code 10007541 Term: Cardiac disorders
Conditions
Interventions
Trade Name: VASOVIST
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GADOFOSVESET
Concentration unit: nmol/ml nanomole(s)/millilitre
Concentration type: equal
Concentration number: 1
Sponsors
OSPEDALE S. RAFFAELE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult patients (18 years and older). 2. Patients who have undergone delayed enhancement cardiac MR imaging with Magnevist within 48 hours ? 2 weeks before the planned Vasovist or Gadovist examination. 3. Patients who have displayed area of delayed enhancement in Magnevist cardiac MR in the clinical interpretation. 4. Patients must be willing and able to continue study participation following the reference test to ensure completion of all procedures and observations required by the study. 5. Fully informed and signed consent must be obtained from each patient. 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: History of severe allergic reaction or allergic reaction to MR contrast media. 2. If female: not pregnant or breast-feeding. 3. Allergy (hypersensitivity) to the active substances or to any excipients of the contrast media under study. 4. Patients not being able to remain lying down for at least 45-60 min (e.g., patients with dyspnea at rest, severe pain at rest, severe back pain) 5. Volunteers presenting with a contraindication to MRI such as pacemaker, aneurysm clip, or severe claustrophobia 6. Uncooperative patients, in the investigator?s opinion 7. Patients affected by severe renal impairment (GFR<30mL/min/1.73m2). 8. Patients participating in another clinical trial. 9. Patients having been previously enrolled in this study. 10. Patients with arrhythmia preventing proper ECG-gating. 11. Patients who received or is going to be received another contrast media 12 hours before and 24 hours after MRI. 12. Patients who have undergone interventional procedure between the two study exams.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of this study is to assess the value of Vasovist and Gadovist for delayed enhancement imaging, taking the extracellular contrast agent Magnevist as the standard of reference.;Secondary Objective: The secondary study objective is to define optimized imaging time points for Vasovist and Gadovist delayed enhanced imaging and to monitor the safety of the two contrast media.;Primary end point(s): The purpose of this study is to assess the value of Vasovist and Gadovist for delayed enhancement imaging, taking the extracellular contrast agent Magnevist as the standard of reference. | — |
Countries
Italy
Outcome results
None listed