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
1 other identifier
observational
2,755
2 countries
36
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Typical duration for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2018
CompletedFirst Posted
Study publicly available on registry
September 14, 2018
CompletedStudy Start
First participant enrolled
November 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2021
CompletedJanuary 11, 2022
January 1, 2022
2.6 years
September 13, 2018
January 6, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
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
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
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
All-Cause Mortality of STEMI Participants Within 30 days after primary PCI
From Baseline up to 30 days post-PCI
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GE Healthcarelead
Study Sites (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
Shijiazhuang First Hospital
Shijiazhuang, Hebei, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Henan University of CM
Zhengzhou, Henan, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Wuhan Central Hospital
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Jiangning Hospital
Nanjing, Jiangsu, China
People's Hospital of Jiangsu Province
Nanjing, Jiangsu, China
China-Japan Friendship Hospital of Jilin University
Changchun, Jilin, China
The Second Hospital of Jilin University
Changchun, Jilin, China
The People's Hospital of Liaoning Province
Shenyang, Liaoning, China
Ankang City Central Hospital
Ankang, Shaanxi, China
Linzi District People's Hospital
Linzi, Shandong, China
Shanxi Province Fenyang Hospital
Fenyang, Shanxi, China
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, China
Taiyuan Central Hospital
Taiyuan, Shanxi, China
Xi'an No.3 Hospital
Xi’an, Shanxi, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Ningbo First People's Hospital
Ningbo, Zhejiang, China
Shaoxing Hospital of Zhejiang University
Shaoxing, Zhejiang, China
Peking University First Hospital
Beijing, China
Wangjing Hospital of CACMS
Beijing, China
Shanghai Tongren Hospital
Shanghai, China
Shanghai Zhongshan Hospital
Shanghai, China
Tianjin Chest Hospital
Tianjin, China
Seoul National University Bundang Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2018
First Posted
September 14, 2018
Study Start
November 5, 2018
Primary Completion
June 7, 2021
Study Completion
June 7, 2021
Last Updated
January 11, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share