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NCT Number: NCT05032937

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

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

domestic polysaccharide superparamagnetic iron oxide nanoparticle

Drug

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 outcomes

  1. 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.

  2. The degree of coronary artery stenosis

    Time frame: 72 hours

    Degree of coronary artery stenosis assessed by quantitative coronary angiography.

  3. 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.

  4. Plaque stability of coronary atherosclerotic plaques

    Time frame: 72 hours

    Plaque stability of coronary atherosclerotic plaques assessed by Optical coherence tomography.

  5. 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.

  6. Blood biochemistry

    Time frame: baseline,72 hours,30 Days,3 months

    Blood biochemistry examination of patients before and after examination to evaluate liver function.

  7. Urine routine

    Time frame: baseline,72 hours,30 Days,3 months

    Urine routine examination of patients before and after examination to evaluate kidney function.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Sep 2, 2021
Registry last updated
Jan 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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