Back to resultsthe Accuracy and Safety of Coronary Artery Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
domestic polysaccharide superparamagnetic iron oxide nanoparticle
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Heart Disease focused on measuring Ultrasmall Superparamagnetic Particles of Iron Oxide, Contrast-Enhanced Magnetic Resonance, Plaque Stability
Eligibility Criteria
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.
Sites / Locations
- First Affiliated Hospital of Nanjing Medical University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ECMR
Arm Description
Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.
Outcomes
Primary Outcome Measures
The degree of coronary artery stenosis
Degree of coronary artery stenosis assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.
The degree of coronary artery stenosis
Degree of coronary artery stenosis assessed by quantitative coronary angiography.
Plaque stability of coronary atherosclerotic plaques
Plaque stability of coronary atherosclerotic plaques assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.
Plaque stability of coronary atherosclerotic plaques
Plaque stability of coronary atherosclerotic plaques assessed by Optical coherence tomography.
Blood routine
Blood routine examination of patients before and after examination to evaluate general condition of patients.
Blood biochemistry
Blood biochemistry examination of patients before and after examination to evaluate liver function.
Urine routine
Urine routine examination of patients before and after examination to evaluate kidney function.
24-hour urine biochemistry
24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.
Retinol binding protein
Retinol binding protein examination of patients before and after examination to evaluate kidney function.
Neutrophil gelatinase-associated lipocalin
Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.
Serum iron
Determination of serum iron before and after ECMR to evaluate the changes of iron content in peripheral blood.
Ferritin
Determination of serum ferritin before and after ECMR to evaluate the changes of iron content in peripheral blood.
Transferrin
Determination of serum transferrin before and after ECMR to evaluate the changes of iron content in peripheral blood.
Change of iron content in tissues between different time points
Evaluation of tissue iron content by T1W MRI before and after ECMR.
Secondary Outcome Measures
Full Information
NCT ID
NCT05032937
First Posted
August 21, 2021
Last Updated
January 11, 2023
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05032937
Brief Title
the Accuracy and Safety of Coronary Artery Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle
Official Title
Clinical Study of Domestic Polysaccharide Superparamagnetic Iron Oxide Nanoparticle Injection for Coronary Artery Contrast-enhanced Magnetic Resonance Contrast-enhanced Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 13, 2021 (Actual)
Primary Completion Date
November 5, 2022 (Actual)
Study Completion Date
January 5, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Ultrasmall Superparamagnetic Particles of Iron Oxide, Contrast-Enhanced Magnetic Resonance, Plaque Stability
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ECMR
Arm Type
Experimental
Arm Description
Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.
Intervention Type
Drug
Intervention Name(s)
domestic polysaccharide superparamagnetic iron oxide nanoparticle
Intervention Description
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.
Primary Outcome Measure Information:
Title
The degree of coronary artery stenosis
Description
Degree of coronary artery stenosis assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.
Time Frame
baseline
Title
The degree of coronary artery stenosis
Description
Degree of coronary artery stenosis assessed by quantitative coronary angiography.
Time Frame
72 hours
Title
Plaque stability of coronary atherosclerotic plaques
Description
Plaque stability of coronary atherosclerotic plaques assessed by contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle.
Time Frame
baseline
Title
Plaque stability of coronary atherosclerotic plaques
Description
Plaque stability of coronary atherosclerotic plaques assessed by Optical coherence tomography.
Time Frame
72 hours
Title
Blood routine
Description
Blood routine examination of patients before and after examination to evaluate general condition of patients.
Time Frame
baseline,72 hours,30 Days,3 months
Title
Blood biochemistry
Description
Blood biochemistry examination of patients before and after examination to evaluate liver function.
Time Frame
baseline,72 hours,30 Days,3 months
Title
Urine routine
Description
Urine routine examination of patients before and after examination to evaluate kidney function.
Time Frame
baseline,72 hours,30 Days,3 months
Title
24-hour urine biochemistry
Description
24-hour urine biochemistry examination of patients before and after examination to evaluate kidney function.
Time Frame
baseline,72 hours,30 Days,3 months
Title
Retinol binding protein
Description
Retinol binding protein examination of patients before and after examination to evaluate kidney function.
Time Frame
baseline,72 hours,30 Days,3 months
Title
Neutrophil gelatinase-associated lipocalin
Description
Neutrophil gelatinase-associated lipocalin examination of patients before and after examination to evaluate kidney function.
Time Frame
baseline,72 hours,30 Days,3 months
Title
Serum iron
Description
Determination of serum iron before and after ECMR to evaluate the changes of iron content in peripheral blood.
Time Frame
baseline,72 hours,30 Days,3 months
Title
Ferritin
Description
Determination of serum ferritin before and after ECMR to evaluate the changes of iron content in peripheral blood.
Time Frame
baseline,72 hours,30 Days,3 months
Title
Transferrin
Description
Determination of serum transferrin before and after ECMR to evaluate the changes of iron content in peripheral blood.
Time Frame
baseline,72 hours,30 Days,3 months
Title
Change of iron content in tissues between different time points
Description
Evaluation of tissue iron content by T1W MRI before and after ECMR.
Time Frame
baseline,6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunjian Li, Dr, PhD
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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the Accuracy and Safety of Coronary Artery Contrast-enhanced Magnetic Resonance Imaging With Polysaccharide Superparamagnetic Iron Oxide Nanoparticle
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