Post-Marketing Safety Study in ST-Segment Elevation Myocardial Infarction (STEMI) Participants Undergoing Primary Percutaneous Coronary Intervention (PCI) Procedure With VISIPAQUE® as the Contrast Medium

Completed

• Conditions: ST-segment Elevation Myocardial Infarction; Coronary Artery Disease
• Interventions: Drug: Iodixanol

• Registration Number: NCT03671603
• Lead Sponsor: GE Healthcare

Brief Summary

The purpose of this study is to prospectively observe the incidence rate of acute kidney injury (AKI), major adverse renal and cardiovascular events (MARCE) in participants who were diagnosed with ST-segment elevation myocardial infarction (STEMI) and have completed primary percutaneous coronary intervention (PCI) procedure following an injection of iso-osmolar contrast medium iodixanol (Visipaque) during the in-hospital period and up to 30 days post-PCI follow-up period. The study will provide a better safety profile of Visipaque as the contrast medium in PCI procedure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Study Start: 2018-11-05
• Primary Completion: 2021-06-07
• Study Completion: 2021-06-07
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2755

Inclusion Criteria

Participants may be included in the study if they meet all of the following criteria:

• The participant is over 18 years' old
• The participant with ST segment elevation myocardial infarction (STEMI) diagnosis has completed primary percutaneous coronary intervention (PCI) procedure and Visipaque was used as the contrast medium in the procedure
• The participant completed pre-procedural serum creatinine (SCr) test at the same hospital where PCI procedure was conducted, and the SCr test should be conducted with the same methodology before and after the procedure
• The participant has signed and dated the written informed consent form

Exclusion Criteria

Participants must be excluded from participating in this study if they meet any of the following criteria:

• The participant has any contraindications to Visipaque (e.g., manifest thyrotoxicosis, history of serious hypersensitivity reaction to iodinated contrast media)
• The participant is pregnant or lactating
• The participant has been previously enrolled in this study
• The participant is currently under renal dialysis
• The participant presents with a terminal (life expectation <1 month), serious, or life-threatening disease, or any medical or psychiatric condition, or any condition where study participation may compromise the management of the participant
• The participant has other reasons that in the judgement of the investigator is unsuitable for participation in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Iodixanol	Iodixanol	Participants will receive Iodixanol 270 mg I/ml or Iodixanol 320 mg I/ml injection as a part of routine clinical practice at the medical discretion of the physician.

Primary Outcome Measures

Name	Time	Method
Assessment of the Incidence Rate of AKI in STEMI Participants Undergoing Primary PCI Using Visipaque	Within 48-72 hours post PCI	AKI which is defined as a serum creatinine (SCr) increase of ≥ 0.3 mg/dL (≥ 26.4 umol/L) or increase to ≥150% (≥1.5-fold) from baseline values within 48-72 hours.

Secondary Outcome Measures

Name	Time	Method
Assessment of the Incidence Rate of MARCE (Except AKI) in STEMI Participants Undergoing Primary PCI Using Visipaque From 72 hours to 30 days Post-PCI	From 72 hours to 30 days post-PCI	MARCE includes cardiac death, re-infarction,TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis.
All-Cause Mortality of STEMI Participants Within 30 days after primary PCI	From Baseline up to 30 days post-PCI
Assessment of the Incidence Rate of MARCE in STEMI Participants Undergoing Primary PCI Using Visipaque Within 72 Hours Post-PCI	Within 72 hours post-PCI	MARCE includes cardiac death, re-infarction, target lesion revascularization (TLR), stent thrombosis, unstable angina, stroke, transient ischemic attack (TIA), AKI, renal failure requiring dialysis.
Assessment of the Incidence Rate of Each Event of MARCE (except AKI) in STEMI Participants Undergoing Primary PCI Using Visipaque Within 72 Hours Post-PCI	Within 72 Hours post-PCI	MARCE includes cardiac death, re-infarction, TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis.
Assessment of the Incidence Rate of Each Event of MARCE (except AKI) in STEMI Participants Undergoing Primary PCI Using Visipaque From 72 hours to 30 Days Post-PCI	From 72 hours to 30 Days post-PCI	MARCE includes cardiac death, re-infarction, TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis.

Trial Locations

Locations (36)

Kaifeng Central Hospital; 🇨🇳 Kaifeng, Contact:, China

The Second Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Gansu, China

Lanzhou University Second Hospital; 🇨🇳 Lanzhou, Gansu, China

The First Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Dongguan Kanghua Hospital; 🇨🇳 Guangdong, Guangdong, China

The First Affiliated Hospital of Jinan University; 🇨🇳 Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Affiliated Hospital of Guangdong Medical University; 🇨🇳 Zhanjiang, Guangdong, China

Hebei General Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Shijiazhuang First Hospital Central Hospital Campus; 🇨🇳 Shijiazhuang, Hebei, China

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