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

The Association of Iodixanol (Visipaque) to Renal Function and Cardiac and Cerebrovascular Events in STEMI Patients Undergoing Primary PCI: A Prospective, Multi-National, Multi-Center, Open-Label, Observational Study

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease; ST-segment Elevation Myocardial Infarction
• Intervention / Treatment: Drug: Iodixanol

• Study Type: Observational
• Enrollment (Actual): 2755

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University First Hospital
  • Beijing, China
    • Wangjing Hospital of CACMS
  • Shanghai, China
    • Shanghai Zhongshan Hospital
  • Shanghai, China
    • shanghai Tongren hospital
  • Tianjin, China
    • Tianjin Chest Hospital
  • Contact:
    • Kaifeng, Contact:, China
      • Kaifeng Central Hospital
  • Gansu
    • Chongqing, Gansu, China
      • The Second Affiliated Hospital of Chongqing Medical University
    • Lanzhou, Gansu, China
      • The First Hospital of Lanzhou University
    • Lanzhou, Gansu, China
      • Lanzhou University Second Hospital
  • Guangdong
    • Guangdong, Guangdong, China
      • Dongguan Kanghua Hospital
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Jinan University
    • Zhanjiang, Guangdong, China
      • Affiliated Hospital of Guangdong Medical University
  • Hebei
    • Shijiazhuang, Hebei, China
      • Hebei General Hospital
    • Shijiazhuang, Hebei, China
      • The Second Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China
      • Shijiazhuang First Hospital Central Hospital Campus
    • Shijiazhuang, Hebei, China
      • Shijiazhuang First Hospital
  • Henan
    • Zhengzhou, Henan, China
      • The First Affiliated Hospital of Henan University of CM
  • Hubei
    • Wuhan, Hubei, China
      • Wuhan Asia Heart Hospital
    • Wuhan, Hubei, China
      • Wuhan Central Hospital
  • Hunan
    • Changsha, Hunan, China
      • The Third Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing Jiangning Hospital
    • Nanjing, Jiangsu, China
      • People's hospital of Jiangsu Province
  • Jilin
    • Changchun, Jilin, China
      • The Second Hospital of Jilin University
    • Changchun, Jilin, China
      • China-Japan friendship Hospital of Jilin university
  • Liaoning
    • Shenyang, Liaoning, China
      • The People's Hospital of Liaoning Province
  • Shaanxi
    • Ankang, Shaanxi, China
      • Ankang City Central Hospital
  • Shandong
    • Linzi, Shandong, China
      • Linzi District People's Hospital
  • Shanxi
    • Fengyang, Shanxi, China
      • Shanxi Province Fenyang Hospital
    • Taiyuan, Shanxi, China
      • Shanxi Cardiovascular Hospital
    • Taiyuan, Shanxi, China
      • Taiyuan Central Hospital
    • Xi'an, Shanxi, China
      • Xi'an No.3 Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Provincial People's Hospital
  • Zhejiang
    • Ningbo, Zhejiang, China
      • Ningbo First People's Hospital
    • Shaoxing, Zhejiang, China
      • Shaoxing Hospital of Zhejiang University
• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will be adult participants with STEMI diagnosis and have completed primary PCI procedure using Visipaque as contrast medium. The participants should complete pre-procedural 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Iodixanol; Iodixanol 270 mgI/ml or 320 mg I/ml injection will be administered as part of clinical practice according to the judgment of the site with regard to medical need.; Other Names: VISIPAQUE®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the Incidence Rate of AKI in STEMI Participants Undergoing Primary PCI Using Visipaque	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.	Within 48-72 hours post PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the Incidence Rate of MARCE in STEMI Participants Undergoing Primary PCI Using Visipaque 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.	Within 72 hours post-PCI
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	MARCE includes cardiac death, re-infarction, TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis.	Within 72 Hours post-PCI
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	MARCE includes cardiac death, re-infarction,TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis.	From 72 hours to 30 days post-PCI
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	MARCE includes cardiac death, re-infarction, TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis.	From 72 hours to 30 Days post-PCI
All-Cause Mortality of STEMI Participants Within 30 days after primary PCI		From Baseline up to 30 days post-PCI

Collaborators and Investigators

• Sponsor: GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Actual): June 7, 2021
• Study Completion (Actual): June 7, 2021

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease; ST Elevation Myocardial Infarction
• Other Study ID Numbers: VIS-16-07 (Other Identifier: GE HealthCare)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No