Using cardiac MRI to assess risk in patients with dilated cardiomyopathy
Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy
Chinese Academy of Medical Sciences, Fuwai Hospital · NCT04990297
This study is testing how cardiac MRI can help doctors understand the risks and better manage patients with dilated cardiomyopathy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2500 (estimated) |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04990297 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients diagnosed with dilated cardiomyopathy (DCM), a condition characterized by reduced left ventricular function and dilation. It aims to utilize cardiac magnetic resonance imaging (CMR) to evaluate cardiac mass, volume, and function, which can aid in risk stratification and differential diagnosis. The study will include patients with a left ventricular ejection fraction of less than 50% and significant dilation, while excluding those with ischemic heart disease or other specific cardiac conditions. The findings could provide valuable insights into the prognosis and management of DCM.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with dilated cardiomyopathy who have a reduced left ventricular ejection fraction and significant left ventricular dilation.
Not a fit: Patients with ischemic heart disease, hypertrophic cardiomyopathy, or other significant cardiac conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance risk assessment and management strategies for patients with dilated cardiomyopathy, potentially improving outcomes.
How similar studies have performed: Previous studies using cardiac magnetic resonance imaging for risk stratification in heart conditions have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. reduced left ventricular ejection fraction (LVEF\<50%) 2. LV end-diastolic volume \>2SD from normal according to normograms corrected by body surface area (BSA) and age. Exclusion Criteria: 1. Any evidence indicating the presence of ischemic heart disease: Coronary angiography, perfusion imaging Medical documentation that indicated the presence of ischemic heart disease An infarct pattern of late gadolinium enhancement on cardiac magnetic resonance studies and/or acute coronary syndrome or coronary revascularization during follow-up 2. Any evidence of hypertrophic cardiomyopathy, or moderate-to-severe valvular disease\[18\], or infiltrative disease (such as amyloidosis, sarcoidosis, Fabry disease) 3. Incessant arrhythmias 4. Inability to lie flat 5. Pregnancy 6. Contraindication to cardiac magnetic resonance including severe claustrophobia, defibrillators, pacemakers, certain types of intracranial aneurysm clips, intraocular metal, and Stage IV/V chronic kidney disease 7. Diabetes mellitus with end organ damage 8. Inability to provide informed consent.
Where this trial is running
Beijing, Beijing Municipality
- Fuwai Hospital — Beijing, Beijing Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Minjie Lu, PhD
- Email: coolkan@163.com
- Phone: +86-10-88396941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Dilated Cardiomyopathy, Single-center Study, dilated cardiomyopathy, cardiovascular magnetic resonance imaging, prognosis