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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03671603
• Other study ID #: VIS-16-07
• Secondary ID: VIS-16-07
• Status: Completed
• Start date: November 5, 2018
• Est. completion date: June 7, 2021

Study information

• Verified date: January 2022
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2755
• Est. completion date: June 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Countries where clinical trial is conducted

China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	All-Cause Mortality of STEMI Participants Within 30 days after primary PCI		From Baseline up to 30 days post-PCI