the Accuracy and Safety of Coronary Artery Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle

January 11, 2023 updated by: Chunjian Li, The First Affiliated Hospital with Nanjing Medical University

Clinical Study of Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle Injection for Coronary Artery Contrast-enhanced Magnetic Resonance Contrast-enhanced Angiography

This is a single-center, prospective, controlled and diagnostic clinical trial which will enroll 30 patients scheduled for coronary angiography in China.Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.In order to evaluate the safety of polysaccharide superparamagnetic iron oxide nanoparticle, patients will detect iron levels in peripheral and tissue before and after the examination.The main indicators of the study are the degree of coronary artery stenosis and the stability of coronary atherosclerotic plaque assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • First Affiliated Hospital of Nanjing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≧ 18 years, < 75 years;
  • Patients who planned coronary angiography ;
  • Patients with normal renal function or CKD stage 1-3;
  • Patients themselves or authorized families to sign informed consent voluntarily.

Exclusion Criteria:

  • Patients who were allergic to iodine contrast agent or had allergic history or allergic constitution to iron and dextran;
  • Patients who can ' t accept magnetic resonance examination because of psychological ( such as autism syndrome ) or physical reasons ( such as metal retention in the body );
  • Malignancies or other comorbid conditions with life expectancy less than 1 year;
  • Pregnant or lactating woman;
  • Hearing impaired persons;
  • Cardiac function grade III-IV;
  • History of coronary stenting or coronary artery bypass grafting;
  • Patients who were taking other iron agents orally or intravenously;
  • Patients with hemosiderin deposition or hemochromatosis;
  • Patients with acute coronary syndromes;
  • Any other patients that researcher deems it's unsuitable to be admitted.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ECMR
Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.
Drug: domestic polysaccharide superparamagnetic iron oxide nanoparticle
Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The degree of coronary artery stenosis
Time Frame: baseline
Degree of coronary artery stenosis assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.
baseline
The degree of coronary artery stenosis
Time Frame: 72 hours
Degree of coronary artery stenosis assessed by quantitative coronary angiography.
72 hours
Plaque stability of coronary atherosclerotic plaques
Time Frame: baseline
Plaque stability of coronary atherosclerotic plaques assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.
baseline
Plaque stability of coronary atherosclerotic plaques
Time Frame: 72 hours
Plaque stability of coronary atherosclerotic plaques assessed by Optical coherence tomography.
72 hours
Blood routine
Time Frame: baseline,72 hours,30 Days,3 months
Blood routine examination of patients before and after examination to evaluate general condition of patients.
baseline,72 hours,30 Days,3 months
Blood biochemistry
Time Frame: baseline,72 hours,30 Days,3 months
Blood biochemistry examination of patients before and after examination to evaluate liver function.
baseline,72 hours,30 Days,3 months
Urine routine
Time Frame: baseline,72 hours,30 Days,3 months
Urine routine examination of patients before and after examination to evaluate kidney function.
baseline,72 hours,30 Days,3 months
24-hour urine biochemistry
Time Frame: baseline,72 hours,30 Days,3 months
24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.
baseline,72 hours,30 Days,3 months
Retinol binding protein
Time Frame: baseline,72 hours,30 Days,3 months
Retinol binding protein examination of patients before and after examination to evaluate kidney function.
baseline,72 hours,30 Days,3 months
Neutrophil gelatinase-associated lipocalin
Time Frame: baseline,72 hours,30 Days,3 months
Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.
baseline,72 hours,30 Days,3 months
Serum iron
Time Frame: baseline,72 hours,30 Days,3 months
Determination of serum iron before and after ECMR to evaluate the changes of iron content in peripheral blood.
baseline,72 hours,30 Days,3 months
Ferritin
Time Frame: baseline,72 hours,30 Days,3 months
Determination of serum ferritin before and after ECMR to evaluate the changes of iron content in peripheral blood.
baseline,72 hours,30 Days,3 months
Transferrin
Time Frame: baseline,72 hours,30 Days,3 months
Determination of serum transferrin before and after ECMR to evaluate the changes of iron content in peripheral blood.
baseline,72 hours,30 Days,3 months
Change of iron content in tissues between different time points
Time Frame: baseline,6 months
Evaluation of tissue iron content by T1W MRI before and after ECMR.
baseline,6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chunjian Li, Dr, PhD, study principal investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 13, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 5, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 012 (Nahrain Medical Research Collective (NMRC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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