Comparison of OPAQUESOL (Shahid Ghazi) and OMNIPAQUE in CT-Scan with contrast
Phase 3
- Conditions
- patients candidat for CT-Scan by contrast media.Other and unspecified disorders of circulatory system
- Registration Number
- IRCT201604094920N7
- Lead Sponsor
- Shahid Ghazi Pharmaceutical Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Patients aged between 45 to 65 years old; Referred subjects for CT-Scan by contrast media; Provided signed and dated informed consent subjects.
Exclusion criteria: Patient with contrast administration in the past 7 days; Subjects have known contra-indication and allergy to contrast administration; Renal insufficiency as defined by GFR < 50; Lactation; Pregnancy; Bronchial asthma; Clinical unstable condition (hemodynamic, respiratory, neurologic); Emergency cases; Hyperthyroidism; End-stage patients.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Image quality. Timepoint: after CT-Scan. Method of measurement: 1 to 10 scoring by investigator.
- Secondary Outcome Measures
Name Time Method Renal Toxicity. Timepoint: Before and 72 hours after injection. Method of measurement: Serum creatinine.;Adverse events of contrast media. Timepoint: During injection, 4 and 72 hours after injection. Method of measurement: Interviewing with patient.