Actively Recruiting

Age: 18Years - 80Years
All Genders
ID06146751

A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus in Patients With Ventricular Aneurysm and After Percutaneous Ventricular Reconstruction

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2024-09-23

320

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

T

The First Affiliated Hospital with Nanjing Medical University

Lead Sponsor

C

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a new imaging method using ferumoxytol-enhanced cardiac magnetic resonance imaging (MRI) to detect blood clots inside the heart in patients with ventricular aneurysm or those who have undergone percutaneous ventricular reconstruction. The study aims to compare this new MRI approach with the commonly used transthoracic echocardiography, which has lower accuracy in detecting these clots. Ferumoxytol is an iron-based contrast agent that may offer safer and more effective imaging, especially for patients with kidney problems. Participants will receive the ferumoxytol-enhanced cardiac MRI along with a transthoracic echocardiography for comparison. The ferumoxytol contrast agent has a long blood circulation time, allowing for detailed and repeated MRI scans. This observational study is non-randomized and includes patients with ventricular aneurysm or those about 180 days after percutaneous ventricular reconstruction. Experts will review imaging results independently to evaluate detection rates. During the study, participants will undergo imaging tests to detect intracardiac thrombus and assess thrombus presence in both dynamic and static heart chambers. Researchers will measure the detection rates of clots from November 2023 to March 2025. The study includes monitoring for safety and tolerability related to the contrast agent. Participants will be involved in scheduled imaging and clinical assessments over the study period.

CONDITIONS

Brief Title

A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance Imaging for the Detection of Intracardiac Thrombus

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years and older, up to 80 years
  • Patients with left ventricular aneurysm detected by transthoracic echocardiography
  • Patients about 180 days after percutaneous ventricular reconstruction
  • Signed informed consent by the patient or authorized family member
Not Eligible

You will not qualify if you...

  • Unable to lie down for any reason
  • Unable to undergo MRI due to psychological or physical reasons, such as claustrophobia or presence of non-antimagnetic metal in the body
  • Known history of iron allergy or hypersensitivity
  • Currently taking other oral or intravenous iron products
  • Presence of haemosiderin deposition or haemochromatosis
  • Pregnant or lactating women
  • Any other condition deemed inappropriate for enrollment by the investigator

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Approximately 1 day

Participants undergo ferumoxytol-enhanced cardiac magnetic resonance imaging and transthoracic echocardiography to detect intracardiac thrombus.

1 visit (in-person)

Long-term Monitoring

Duration - From enrollment until March 31, 2025

Participants are observed to evaluate the detection rate of intracardiac thrombus over time after imaging.

Additional assessments may occur depending on clinical follow-up

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Actively Recruiting

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Research Team

C

Chunjian Li, MD, PhD

Z

Zhenyu Lin, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC).

Borja Ibanez, Stefan James, Stefan Agewall...

https://pubmed.ncbi.nlm.nih.gov/28886621

2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.

Patrick T O'Gara, Frederick G Kushner, Deborah D Ascheim...

https://pubmed.ncbi.nlm.nih.gov/23247304

Clinical, imaging, and pathological characteristics of left ventricular thrombus: a comparison of contrast-enhanced magnetic resonance imaging, transthoracic echocardiography, and transesophageal echocardiography with surgical or pathological validation.

Monvadi B Srichai, Chelif Junor, L Leonardo Rodriguez...

https://pubmed.ncbi.nlm.nih.gov/16824834

Risk of nephrogenic systemic fibrosis: evaluation of gadolinium chelate contrast agents at four American universities.

Rebecca Wertman, Ersan Altun, Diego R Martin...

https://pubmed.ncbi.nlm.nih.gov/18632533