NCT07351838 Cardiac Magnetic Resonance for Risk Stratification in Non-dilated Left Ventricular Cardiomyopathy
| NCT ID | NCT07351838 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital |
| Condition | Non-ischemic Cardiomyopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2010-01-01 |
| Primary Completion | 2028-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 1,000 participants in total. It began in 2010-01-01 with a primary completion date of 2028-12-30.
⚠ 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
Non-dilated left ventricular cardiomyopathy (NDLVC), a newly defined cardiomyopathy subtype characterized by non-ischemic myocardial abnormalities without left ventricular dilation, poses challenges in prognosis assessment and risk stratification. This is a retrospective observational study aiming to explore the prognostic value of cardiac magnetic resonance (CMR) findings and identify key risk factors for adverse cardiovascular outcomes in patients with NDLVC. We will retrospectively enroll patients diagnosed with NDLVC who underwent CMR examination at the study institution during the predefined study period. CMR parameters, including left ventricular ejection fraction (LVEF), late gadolinium enhancement (LGE) patterns, myocardial strain, and the extent of myocardial fibrosis or fatty replacement, will be extracted and analyzed. The primary endpoint is a composite of major adverse cardiovascular events (MACE), including all-cause mortality, heart transplantation, or left ventricular assist device (LVAD) implantation. The study intends to clarify the association between specific CMR features and long-term prognosis in NDLVC patients, thereby establishing a CMR-based risk stratification strategy to guide clinical decision-making and improve patient outcomes. Given the retrospective nature, data will be collected from electronic medical records and CMR databases, with ethical approval obtained prior to study initiation.
Eligibility Criteria
Inclusion Criteria: * age ≥ 16 years; * indexed left ventricular end-diastolic volume (LVEDVi) \<96 mL/m2 in females and \<105 mL/m2 in males at baseline cardiac magnetic resonance (CMR); * either left ventricular ejection fraction (LVEF) \<50% and/or non-ischemic left ventricular (LV) scar/fatty replacement at baseline cardiac magnetic resonance. Exclusion Criteria: * lacked enhanced CMR images due to contraindications for receiving gadolinium contrast, such as severe renal disease; * ischemic heart disease, defined as stenosis of \>50% in a major epicardial coronary artery underwent coronary computed tomography angiography or coronary angiography, ischemic late gadolinium enhancement (LGE) pattern on CMR indicating prior infarction, or prior coronary revascularization; * abnormal loading conditions, defined as moderate to severe valvular heart diseases, congenital heart diseases, uncontrolled hypertension; * systemic rheumatologic diseases or sarcoidosis; * diagnostic criteria for other cardiomyopathies according to the European Society of Cardiology (ESC) definitions.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07351838 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Non-ischemic Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07351838 currently recruiting?
Yes, NCT07351838 is actively recruiting participants. Contact the research team at coolkan@163.com for enrollment information.
Where is the NCT07351838 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07351838 clinical trial?
NCT07351838 is sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 1,000 participants.