Clinical trial NCT03671603: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
ST-segment Elevation Myocardial Infarction
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 2755
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Assessment of the Incidence Rate of AKI in STEMI Participants Undergoing Primary PCI Using Visipaque
timeFrame: Within 48-72 hours post PCI
Secondary outcomes:
measure: Assessment of the Incidence Rate of MARCE in STEMI Participants Undergoing Primary PCI Using Visipaque Within 72 Hours Post-PCI
timeFrame: Within 72 hours post-PCI
measure: 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
timeFrame: Within 72 Hours post-PCI
measure: 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
timeFrame: From 72 hours to 30 days post-PCI
measure: 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
timeFrame: From 72 hours to 30 Days post-PCI
measure: All-Cause Mortality of STEMI Participants Within 30 days after primary PCI
timeFrame: From Baseline up to 30 days post-PCI
Other outcomes:
Locations:
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
state: Contact:
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Gansu
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Lanzhou
country: China
facility: The First Hospital of Lanzhou University
state: Gansu
city: Guangdong
country: China
facility: Dongguan Kanghua Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Jinan University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical University
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei General Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Shijiazhuang First Hospital Central Hospital Campus
state: Hebei
city: Shijiazhuang
country: China
facility: Shijiazhuang First Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of CM
state: Henan
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Wuhan
country: China
facility: Wuhan Central Hospital
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Nanjing Jiangning Hospital
state: Jiangsu
city: Nanjing
country: China
facility: People's Hospital of Jiangsu Province
state: Jiangsu
city: Changchun
country: China
facility: China-Japan Friendship Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The People's Hospital of Liaoning Province
state: Liaoning
city: Ankang
country: China
facility: Ankang City Central Hospital
state: Shaanxi
city: Linzi
country: China
facility: Linzi District People's Hospital
state: Shandong
city: Fengyang
country: China
facility: Shanxi Province Fenyang Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Taiyuan Central Hospital
state: Shanxi
city: Xi'an
country: China
facility: Xi'an No.3 Hospital
state: Shanxi
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Ningbo
country: China
facility: Ningbo First People's Hospital
state: Zhejiang
city: Shaoxing
country: China
facility: Shaoxing Hospital of Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Wangjing Hospital of CACMS
city: Shanghai
country: China
facility: Shanghai Tongren Hospital
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
city: Tianjin
country: China
facility: Tianjin Chest Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References: