A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Superparamagnetic Iron Oxide Nanoparticles.
- Who it may be relevant to
- Registry conditions: Coronary Artery Calcification. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Diagnostic Performance of a Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries: A Single-center Clinical Study.
Overview
This study is a single-center, prospective, controlled, diagnostic study. The study will be consecutive and is expected to enroll 100 patients with CCTA confirmed coronary calcified lesions. The purpose of this study was to compare the accuracy of novel Ferumoxytol-enhanced Cardiac Magnetic Resonance (Fe-CMR) and coronary CT angiography (CCTA) in detecting calcified coronary arteries, using coronary angiography (CAG) and optical coherence imaging (OCT) as gold standards.
Interventions
- Drug Superparamagnetic Iron Oxide Nanoparticles
Patients will receive a novel ferumoxytol-enhanced cardiac magnetic resonance imaging.
Primary outcome measures
- Degree of vascular stenosis at the site of coronary calcification. [Time frame: baseline]
Secondary outcome measures (3)
- CT-FFR, Agatston score, and the angle of calcification lesions occupying vascular lumen [Time frame: baseline]
- calcium score of the plaque measured by OCT [Time frame: baseline]
- Fe-CMRA image quality score [Time frame: baseline]
Eligibility criteria
Inclusion criteria
- Age ≥18 years, <75 years;
- Imaging specialists evaluate CCTA images taken within 30 days and report that calcification occupied one or more of the patient's vascular lumen at an angle of >50% (using the coronary artery segmentation method recommended by the American Heart Association, including nine segments of the major branches of the coronary artery);
- Patient who will undergo coronary angiography;
- Patient with normal renal function or chronic renal insufficiency (CKD) stage 1-3;
- Patient who signs the informed consent.
Exclusion criteria
- People who are allergic to iodine contrast media or have a history of allergy to iron or dextran or are allergic themselves;
- Because of psychological (such as suffering from claustrophobic syndrome) or physical reasons (such as the presence of metal objects in the body) can not receive MRI examination;
- suffering from terminal diseases (such as malignant tumors) or life expectancy < 1 year;
- Pregnant or lactating women;
- People with limited hearing;
- Patients with grade III-IV heart function;
- Patients with a history of coronary artery stent implantation or coronary artery bypass;
- Other iron agents are being used orally or intravenously;
- Patients with hemosiderosis or hemochromatosis;
- Patients with acute coronary syndrome;
- Patients with hyperthyroidism;
- Any other candidates deemed unsuitable by the researchers.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- First Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT07400406 · 028