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AzTrials

Coronary Artery DiseaseNCT03671603

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

An observational study of Coronary Artery Disease and ST-segment Elevation Myocardial Infarction, run by GE Healthcare at 36 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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)… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Iodixanol
Type of treatment
Injection or infusion
How many people
2,755 participants
Where
36 sitesin 2 countries
Study dates
5 Nov 2018to 7 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

36 sites in 2 countries.

36 sites in 2 countries

China35 sites

  • Ankang City Central Hospital

    Ankang, Shaanxi

  • Peking University First Hospital

    Beijing

  • Wangjing Hospital of CACMS

    Beijing

  • China-Japan Friendship Hospital of Jilin University

    Changchun, Jilin

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Gansu

  • Shanxi Province Fenyang Hospital

    Fenyang, Shanxi

  • Dongguan Kanghua Hospital

    Guangdong, Guangdong

  • The First Affiliated Hospital of Jinan University

    Guangzhou, Guangdong

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

  • Kaifeng Central Hospital

    Kaifeng, Contact:

  • Lanzhou University Second Hospital

    Lanzhou, Gansu

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

  • Linzi District People's Hospital

    Linzi, Shandong

  • Nanjing Jiangning Hospital

    Nanjing, Jiangsu

  • People's Hospital of Jiangsu Province

    Nanjing, Jiangsu

  • Ningbo First People's Hospital

    Ningbo, Zhejiang

  • Shanghai Tongren Hospital

    Shanghai

  • Shanghai Zhongshan Hospital

    Shanghai

  • Shaoxing Hospital of Zhejiang University

    Shaoxing, Zhejiang

  • The People's Hospital of Liaoning Province

    Shenyang, Liaoning

  • Hebei General Hospital

    Shijiazhuang, Hebei

  • Shijiazhuang First Hospital Central Hospital Campus

    Shijiazhuang, Hebei

  • Shijiazhuang First Hospital

    Shijiazhuang, Hebei

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Shanxi Cardiovascular Hospital

    Taiyuan, Shanxi

  • Taiyuan Central Hospital

    Taiyuan, Shanxi

  • Tianjin Chest Hospital

    Tianjin

  • Wuhan Asia Heart Hospital

    Wuhan, Hubei

  • Wuhan Central Hospital

    Wuhan, Hubei

  • Xi'an No.3 Hospital

    Xi’an, Shanxi

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong

  • The First Affiliated Hospital of Henan University of CM

    Zhengzhou, Henan

Other trials in China

South Korea1 site

  • Seoul National University Bundang Hospital

    Seoul

Other trials in South Korea

About this study

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

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.

Being tested
Iodixanol
Medical subject headings
Coronary Artery Disease, ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IodixanolDrug

    Also called VISIPAQUE®

    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.

Study groups in NCT03671603
Study groupRoleWhat they receive
IodixanolParticipants 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.
Receives: Drug: Iodixanol

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 48-72 hours post PCI

Secondary outcomes (5)

  1. 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.

    Measured: Within 72 hours post-PCI

  2. 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.

    Measured: Within 72 Hours post-PCI

  3. 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.

    Measured: From 72 hours to 30 days post-PCI

  4. 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.

    Measured: From 72 hours to 30 Days post-PCI

  5. All-Cause Mortality of STEMI Participants Within 30 days after primary PCI

    Measured: From Baseline up to 30 days post-PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2018
  2. Study start5 Nov 2018
  3. Primary completion7 Jun 2021
  4. Study completion7 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
2,755 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03671603
Sponsor's protocol ID
VIS-16-07
Other IDs
VIS-16-07
Status last verified
Jan 2022
First submitted
13 Sep 2018
Last updated
11 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and ST-segment Elevation Myocardial Infarction, run by GE Healthcare at 36 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the Incidence Rate of AKI in STEMI Participants Undergoing Primary PCI Using Visipaque (time frame: Within 48-72 hours post PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03671603.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.

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