IMPERIAL Study

Incidence of Major Adverse Cardiovascular and Cerebrovascular Events in Chinese Patients Undergoing Percutaneous Coronary Interventions with Iodixanol – A Non Interventional Post-Authorisation Study

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR-ONC-13003733

Enrollment

Unknown

Registered

2013-10-15

Start date

2013-10-22

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

MACCE

Interventions

Case series:iodixanol 320 mg I/mL in patients undergoing PCI

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) The subject<18 years old; (2) The subject has provided a signed and dated informed consent; (3) Patients with obstructive coronary artery disease who are scheduled to undergo PCI with iodixanol 320 mg I/mL.

Exclusion criteria

Exclusion criteria: (1) Patients who have any contraindication to iodixanol (e.g., manifest thyrotoxicosis, history of serious hypersensitivity reaction to iodinated contrast media); (2) Subjects who cannot discontinue metformin following the SPC of iodixanol; (3) Subject has been previously enrolled in this study; (4) Subject presents with a terminal, serious, or life-threatening disease, any medical or psychiatric condition, or any condition where study participation may compromise the management of the subject, or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study.

Design outcomes

Primary

Measure	Time frame
The overall incidence rate of major adverse cardiovascular and cerebrovascular events (MACCE) from PCI to 72 hours post-PCI;	—

Secondary

Measure	Time frame
The incidence rate of MACCEs from 72-hours to 30 days post-PCI.;The difference between incidence rate of MI based on the 2012 Universal definition and incidence rate of MI based on 2011 Universal definition (Levine et al, 2011, Thygesen et al. 2007) from PCI to day 30 after PCI;In-hospital incidence rate of Noncardiac death;In-hospital incidence rates of Clinically significant arrhythmia requiring therapy;In-hospital incidence rate of CI-AKI;In-hospital incidence rates of Hypotension requiring intervention;In-hospital incidence rate of CI-AKI;In-hospital incidence rate of Bleeding complications;The cumulative rate of composite angiographic or procedural complications during or immediately after PCI;The incidence rates of all adverse events from the administration of iodixanol to 3 days post-PCI;	—

Measure

Time frame

The incidence rate of MACCEs from 72-hours to 30 days post-PCI.;The difference between incidence rate of MI based on the 2012 Universal definition and incidence rate of MI based on 2011 Universal definition (Levine et al, 2011, Thygesen et al. 2007) from PCI to day 30 after PCI;In-hospital incidence rate of Noncardiac death;In-hospital incidence rates of Clinically significant arrhythmia requiring therapy;In-hospital incidence rate of CI-AKI;In-hospital incidence rates of Hypotension requiring intervention;In-hospital incidence rate of CI-AKI;In-hospital incidence rate of Bleeding complications;The cumulative rate of composite angiographic or procedural complications during or immediately after PCI;The incidence rates of all adverse events from the administration of iodixanol to 3 days post-PCI;

—

Countries

China

Contacts

Public ContactHAN Yanling

The General Hospital of Shenyang Military Region

hanyaling@263.net+86 024-28897309

Outcome results

None listed

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