Clinical trial NCT05032937: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Heart Disease
Keywords: Ultrasmall Superparamagnetic Particles of Iron Oxide
Contrast-Enhanced Magnetic Resonance
Plaque Stability
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
First posted: 2021-09-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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.

Primary outcomes:
measure: The degree of coronary artery stenosis
timeFrame: baseline
measure: The degree of coronary artery stenosis
timeFrame: 72 hours
measure: Plaque stability of coronary atherosclerotic plaques
timeFrame: baseline
measure: Plaque stability of coronary atherosclerotic plaques
timeFrame: 72 hours
measure: Blood routine
timeFrame: baseline,72 hours,30 Days,3 months
measure: Blood biochemistry
timeFrame: baseline,72 hours,30 Days,3 months
measure: Urine routine
timeFrame: baseline,72 hours,30 Days,3 months
measure: 24-hour urine biochemistry
timeFrame: baseline,72 hours,30 Days,3 months
measure: Retinol binding protein
timeFrame: baseline,72 hours,30 Days,3 months
measure: Neutrophil gelatinase-associated lipocalin
timeFrame: baseline,72 hours,30 Days,3 months
measure: Serum iron
timeFrame: baseline,72 hours,30 Days,3 months
measure: Ferritin
timeFrame: baseline,72 hours,30 Days,3 months
measure: Transferrin
timeFrame: baseline,72 hours,30 Days,3 months
measure: Change of iron content in tissues between different time points
timeFrame: baseline,6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Study Principal Investigator
name: Chunjian Li, Dr, PhD
role: PRINCIPAL_INVESTIGATOR
References: