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
NCT ID: NCT03671603
Last Updated: 2022-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2755 participants
OBSERVATIONAL
2018-11-05
2021-06-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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GE Healthcare
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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VIS-16-07
Identifier Type: OTHER
Identifier Source: secondary_id
VIS-16-07
Identifier Type: -
Identifier Source: org_study_id
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