NCT04990297 Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy
| NCT ID | NCT04990297 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital |
| Condition | Dilated Cardiomyopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,500 participants |
| Start Date | 2019-12-24 |
| Primary Completion | 2030-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,500 participants in total. It began in 2019-12-24 with a primary completion date of 2030-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Dilated cardiomyopathy (DCM) is an increasingly recognized cause of morbidity and mortality with heterogenous etiologies (eg, genetic, environment) and clinical manifestations, characterized by left ventricular (LV) systolic dysfunction and LV or biventricular dilation. Previous publications reported the three-year treated mortality rates remain high at 12%-20% and a reported 5-year mortality rate up to 50%, with death resulting from ventricular arrhythmia leading to sudden cardiac death (SCD) or advanced heart failure (HF). With large fields of view and high spatial resolution, Cardiac magnetic resonance (CMR) is the reference standard for assessing cardiac mass, volume, and function. CMR also provides non noninvasive characterization of the myocardium benefiting to differential diagnosis and risk stratification.
Eligibility 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.
Contact & Investigator
Minjie Lu, PhD
STUDY CHAIR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT04990297 clinical trial?
This trial is open to participants of all sexes, studying Dilated Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04990297 currently recruiting?
Yes, NCT04990297 is actively recruiting participants. Contact the research team at coolkan@163.com for enrollment information.
Where is the NCT04990297 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT04990297 clinical trial?
NCT04990297 is sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. The principal investigator is Minjie Lu, PhD at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 2,500 participants.