Skip to content

Post-Marking Surveillance of the Safety Profile of Domestic Iodixanol in CT Examination of Chinese Patients

Post-Marking Surveillance of the Safety Profile of Domestic Iodixanol in CT Examination of Chinese Patients

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900024539
Enrollment
Unknown
Registered
2019-07-15
Start date
2019-08-12
Completion date
Unknown
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disease of every system

Interventions

Grouped by gender, age and other factors:Iodixanol

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Aged over 18 years; (2) Coronary CT angiography, enhanced CT in all parts and large vessel CTA are needed; (3) Subjects were able and willing to comply with all the requirements of examination.

Exclusion criteria

Exclusion criteria: (1) Patients with serious adverse reactions to ioxanol in the past; (2) Uncontrolled hyperthyroidism; (3) Pregnant women and lactating women; (4) Suffering from serious life-threatening diseases, life expectancy less than 2 months; (5) Subjects refused or could not discontinue taking metformin hydrochloride or drug with metformin hydrochloride within 48 hours before using the drug; (6) Subjects were unable to comply with or tolerate the necessary fluid supplementation procedures; (7) Patients with major mental illness or consciousness disorder, researchers believe that this factor will affect the successful extraction of effective images.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse reactions;

Secondary

MeasureTime frame
The correlation analysis between risk factors and incidence of adverse reactions;

Countries

China

Contacts

Public ContactChunhong Hu

The First Affiliated Hospital of Soochow University

hch5305@163.com+86 13506219750

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026