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

Sponsor

GE Healthcare (Industry)

Overall Status

Completed

CT.gov ID

NCT03671603

Collaborator

(none)

2,755

Enrollment

Locations

Actual Duration (Months)

76.5

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease ST-segment Elevation Myocardial Infarction	Drug: Iodixanol

Study Design

Study Type:

Observational

Actual Enrollment :

2755 participants

Observational Model:

Other

Time Perspective:

Prospective

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

Actual Study Start Date :

Nov 5, 2018

Actual Primary Completion Date :

Jun 7, 2021

Actual Study Completion Date :

Jun 7, 2021

Arms and Interventions

Arm	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®

Arm

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®

Outcome Measures

Primary Outcome Measures

Assessment of the Incidence Rate of AKI in STEMI Participants Undergoing Primary PCI Using Visipaque [Within 48-72 hours post PCI]
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.

Secondary Outcome Measures

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]
MARCE includes cardiac death, re-infarction, target lesion revascularization (TLR), stent thrombosis, unstable angina, stroke, transient ischemic attack (TIA), AKI, renal failure requiring dialysis.
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]
MARCE includes cardiac death, re-infarction, TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis.
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]
MARCE includes cardiac death, re-infarction,TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis.
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]
MARCE includes cardiac death, re-infarction, TLR, stent thrombosis, unstable angina, stroke, TIA, AKI, renal failure requiring dialysis.
All-Cause Mortality of STEMI Participants Within 30 days after primary PCI [From Baseline up to 30 days post-PCI]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country
1	Kaifeng Central Hospital	Kaifeng	Contact:	China
2	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Gansu	China
3	Lanzhou University Second Hospital	Lanzhou	Gansu	China
4	The First Hospital of Lanzhou University	Lanzhou	Gansu	China
5	Dongguan Kanghua Hospital	Guangdong	Guangdong	China
6	The First Affiliated Hospital of Jinan University	Guangzhou	Guangdong	China
7	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China
8	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong	China
9	Hebei General Hospital	Shijiazhuang	Hebei	China
10	Shijiazhuang First Hospital Central Hospital Campus	Shijiazhuang	Hebei	China
11	Shijiazhuang First Hospital	Shijiazhuang	Hebei	China
12	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei	China
13	The First Affiliated Hospital of Henan University of CM	Zhengzhou	Henan	China
14	Wuhan Asia Heart Hospital	Wuhan	Hubei	China
15	Wuhan Central Hospital	Wuhan	Hubei	China
16	The Third Xiangya Hospital of Central South University	Changsha	Hunan	China
17	Nanjing Jiangning Hospital	Nanjing	Jiangsu	China
18	People's Hospital of Jiangsu Province	Nanjing	Jiangsu	China
19	China-Japan Friendship Hospital of Jilin University	Changchun	Jilin	China
20	The Second Hospital of Jilin University	Changchun	Jilin	China
21	The People's Hospital of Liaoning Province	Shenyang	Liaoning	China
22	Ankang City Central Hospital	Ankang	Shaanxi	China
23	Linzi District People's Hospital	Linzi	Shandong	China
24	Shanxi Province Fenyang Hospital	Fengyang	Shanxi	China
25	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi	China
26	Taiyuan Central Hospital	Taiyuan	Shanxi	China
27	Xi'an No.3 Hospital	Xi'an	Shanxi	China
28	Sichuan Provincial People's Hospital	Chengdu	Sichuan	China
29	Ningbo First People's Hospital	Ningbo	Zhejiang	China
30	Shaoxing Hospital of Zhejiang University	Shaoxing	Zhejiang	China
31	Peking University First Hospital	Beijing		China
32	Wangjing Hospital of CACMS	Beijing		China
33	Shanghai Tongren Hospital	Shanghai		China
34	Shanghai Zhongshan Hospital	Shanghai		China
35	Tianjin Chest Hospital	Tianjin		China
36	Seoul National University Bundang Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

GE Healthcare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GE Healthcare

ClinicalTrials.gov Identifier:

NCT03671603

Other Study ID Numbers:

VIS-16-07
VIS-16-07

First Posted:

Sep 14, 2018

Last Update Posted:

Jan 11, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Coronary Artery Disease

Myocardial Infarction

ST Elevation Myocardial Infarction

Infarction

Study Results

No Results Posted as of Jan 11, 2022